tag:theconversation.com,2011:/uk/topics/crispr-15704/articlesCRISPR – The Conversation2019-09-03T12:53:14Ztag:theconversation.com,2011:article/1214732019-09-03T12:53:14Z2019-09-03T12:53:14ZGenetic engineering and human-animal hybrids: how China is leading a global split in controversial research<figure><img src="https://images.theconversation.com/files/290754/original/file-20190903-175678-1508peu.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/medical-doctors-looking-futuristic-tablet-device-1085160959?src=-2-60">metamorworks/Shutterstock</a></span></figcaption></figure><p>If you want to conduct groundbreaking but contentious biological research, go to China. Last year, Chinese scientist He Jiankui announced he had created the world’s <a href="https://theconversation.com/how-a-scientist-says-he-made-a-gene-edited-baby-and-what-health-worries-may-ensue-107764">first gene-edited human babies</a>, shocking the world at a time when such practice is illegal in most leading scientific nations. More recently, US-based researcher Juan Carlos Izpisua Belmonte revealed he had produced the world’s <a href="https://elpais.com/elpais/2019/07/31/inenglish/1564561365_256842.html">first human-monkey hybrid</a> embryo in China to avoid legal issues in his adopted country.</p>
<p>Yet if China is fast becoming the world capital of controversial science, it is not alone in producing it. More babies produced using the “CRISPR” gene-editing technology <a href="https://www.nature.com/articles/d41586-019-01770-x">are now planned</a> by a scientist in Russia, where another researcher is also hoping to conduct the world’s <a href="https://theconversation.com/the-problem-with-human-head-transplants-53522">first human head transplant</a>. And Japan has <a href="https://theconversation.com/human-animal-hybrids-are-coming-and-could-be-used-to-grow-organs-for-transplant-a-philosopher-weighs-in-121228">recently lifted</a> its own ban on human-animal hybrids.</p>
<p>The world is rapidly moving towards a two-tier system of cutting-edge medical research, broadly divided between countries with minimal regulation and those that refuse to allow anything but the earliest stages of this work. The consequences of this split are likely to be significant, even potentially affecting your own access to healthcare.</p>
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<img alt="" src="https://images.theconversation.com/files/290743/original/file-20190903-175700-15ol419.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/290743/original/file-20190903-175700-15ol419.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=338&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/290743/original/file-20190903-175700-15ol419.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=338&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/290743/original/file-20190903-175700-15ol419.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=338&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/290743/original/file-20190903-175700-15ol419.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=424&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/290743/original/file-20190903-175700-15ol419.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=424&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/290743/original/file-20190903-175700-15ol419.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=424&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">He Jiankui.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:He_Jiankui.jpg">The He Lab/Wikipedia</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
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<p>The births of the CRISPR babies in China <a href="https://www.nature.com/articles/d41586-019-00673-1">led to uproar</a> among the scientific community, which <a href="https://theconversation.com/worlds-first-gene-edited-babies-premature-dangerous-and-irresponsible-107642">criticised He Jiankui</a>, and inspired <a href="https://theconversation.com/experts-call-for-halt-to-crispr-editing-that-allows-gene-changes-to-pass-on-to-children-113463">calls for a halt</a> in any CRISPR research on human embryos. <a href="https://rbej.biomedcentral.com/articles/10.1186/1477-7827-12-108">In around 30 countries</a>, gene editing of human embryos is already banned outright or at least tightly controlled. For example, in the UK only a handful of research groups have been <a href="https://www.crick.ac.uk/research/labs/kathy-niakan/human-embryo-genome-editing-licence">granted a licence</a> to conduct experiments, and certainly not with any aim of bringing an embryo to term.</p>
<p>But in most countries, things are <a href="https://socialandlegalstudies.wordpress.com/2019/07/12/whats-law-got-to-do-with-human-germline-editing/">less clear</a>. The Chinese establishment was <a href="https://www.theguardian.com/science/2018/nov/29/work-on-gene-edited-babies-blatant-violation-of-the-law-says-china">quick to condemn</a> He’s work and declare it illegal. And some commentators have <a href="https://www.theatlantic.com/science/archive/2018/11/china-crispr-babies/576784/">made the point</a> that, despite outside perceptions, Chinese science is far from unregulated. Yet the fact remains that He was able to conduct the work unimpeded, with evidence suggesting he may have even received <a href="https://www.theverge.com/2019/2/26/18241382/crispr-babies-chinese-government-he-jiankui-bioethics-science-health">state funding</a>.</p>
<p>With a technology moving as <a href="https://theconversation.com/uk/topics/crispr-15704">quickly as CRISPR</a>, many nations will not have had the time nor expertise to develop a comprehensive stance. As a result, it seems likely that we won’t be able to avoid a two-tier system for this kind of research. Nations with developed regulation for biotechnology will be able to adapt more quickly and easily to the latest advances and put restrictions in place. Other states will scramble to keep up, leaving scientists to proceed without having to consider the ethical or social implications of their work. And that’s assuming all governments want to restrict this kind of research, which they may not.</p>
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<img alt="" src="https://images.theconversation.com/files/290685/original/file-20190903-175682-jomjl9.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/290685/original/file-20190903-175682-jomjl9.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=338&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/290685/original/file-20190903-175682-jomjl9.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=338&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/290685/original/file-20190903-175682-jomjl9.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=338&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/290685/original/file-20190903-175682-jomjl9.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=424&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/290685/original/file-20190903-175682-jomjl9.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=424&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/290685/original/file-20190903-175682-jomjl9.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=424&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Not all countries may want to restrict gene editing.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/innovative-technologies-science-medicine-mixed-media-493402678">Sergey Nevens/Shutterstock</a></span>
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<p>We have seen what happens when there is this kind of international disconnect with other biotechnologies. “Medical tourism” has become a <a href="https://doi.org/10.1016/j.amjmed.2018.06.022">boom sector</a> within the healthcare industry. People travel from all over the world to private clinics that provide – or <a href="https://www.nytimes.com/2016/06/23/health/a-cautionary-tale-of-stem-cell-tourism.html">claim to provide</a> – stem cell therapies unavailable in their home countries. There have been high-profile cases of people travelling from the <a href="https://ipscell.com/2016/09/mitochondrial-replacement-techniques-mexican-case/">US to Mexico</a> in order to skirt national laws and access mitochondrial replacement therapy. </p>
<p>So it’s safe to assume that those with the means to do so might try to access gene editing abroad when it’s not available in their own countries, perhaps to avoid passing on a known heritable condition they carry. And with home DNA-testing kits becoming widespread (<a href="https://www.scientificamerican.com/article/how-accurate-are-online-dna-tests/">although not necessarily accurate</a>), the number of people wanting to edit their genome before having children is likely to increase.</p>
<p>A lack of or loose medical regulations also tends to produce predatory clinics that <a href="https://www.imtj.com/blog/stem-cell-therapies-show-medical-tourisms-darker-side/">charge huge amounts</a> for what sounds like wonder cures but might be, at best, a sugar pill or, at worst, <a href="https://stemcellsjournals.onlinelibrary.wiley.com/doi/epdf/10.1002/sctm.17-0282">something actively harmful</a>. And, perhaps worst of all, regulatory problems might contribute to destroying the reputation of promising developing medical technologies. The more nasty incidents that are attributed to an unregulated therapy, the less and less willing people will be to support legitimate medical trials.</p>
<p>This kind of two-tier system of medical regulation could also lead techniques such as gene-editing to become much more culturally accepted in some countries than others. Our society continues to struggle with xenophobia and racism, so we may also find prejudices and legal dilemmas developing for genetically engineered humans (never mind human-animal hybrids).</p>
<p>Would people born using technologies such as CRISPR be allowed to visit or emigrate to countries where their very creation was illegal? Would it be illegal for them to have their own children and spread their genetically altered genome? This kind of conflict between international human rights legislation and domestic policy is yet to be tested but could have grave consequences.</p>
<h2>Worsening health inequality</h2>
<p>On the other side of the divide, if countries with strong regulations move too slowly to allow treatments that may be lifesaving or disability preventing, it could worsen health inequality. We already have serious global problems with <a href="http://www.jpe.ox.ac.uk/papers/biotechnology-justice-and-health/">distributive justice</a>, the ways in which services or technologies are only accessible to the privileged. If a particular illness could be prevented through CRISPR, is it right that someone should have to risk their child developing the disease just because they cannot afford to travel to a country where the technique is legal?</p>
<p>Unfortunately, the obvious solution – internationally agreed standards and regulations – may be a pipedream. We have consistently failed to find <a href="https://www.oxfordhandbooks.com/view/10.1093/oxfordhb/9780199680832.001.0001/oxfordhb-9780199680832-e-58">global consensus</a> on gene editing issues, just as with embryo research. Even if it is possible to reach common ground, developing and implementing mutually acceptable terms that are flexible enough to handle the inevitable further technological progress, will take many years. For now, proposals for <a href="https://www.nature.com/articles/d41586-018-03270-w">concerted effort to keep track</a> of gene editing research may be the best we can do.</p>
<p>It’s difficult to predict what could happen in the meantime. But it seems likely that more and more gene editing and other controversial practices will take place in a variety of regulated and unregulated circumstances. Sadly, it may be the case that little progress is made until the types of problems outlined above become all too real.</p><img src="https://counter.theconversation.com/content/121473/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>David Lawrence does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A growing international divide over cutting-edge medical research could worsen predatory practices, medical tourism and health inequality.David Lawrence, Postdoctoral Fellow, Newcastle Law School, Newcastle UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1219122019-08-15T11:14:47Z2019-08-15T11:14:47ZWhat's the right way for scientists to edit human genes? 5 essential reads<figure><img src="https://images.theconversation.com/files/288064/original/file-20190814-136222-xtmn4o.jpg?ixlib=rb-1.1.0&amp;rect=431%2C449%2C5290%2C3520&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Ethical frameworks, rules, laws: all try to have their say.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/doctor-prepares-special-media-growing-embryos-1447342460?src=XFXBbEV0tU5iihvrK1Vv0A-1-12">Tati9/Shutterstock.com</a></span></figcaption></figure><p>Since scientists first figured out how to edit genes with precision using a technology called CRISPR, they’ve been grappling with when and how to do it ethically. Is it reasonable to edit human genes with CRISPR? What about human genes in reproductive cells that pass the edits on to future generations?</p>
<p>The <a href="http://nationalacademies.org/gene-editing/international-commission/index.htm?_ga=2.266036175.1969896713.1565792406-1004430421.1565792406">International Commission on the Clinical Use of Human Germline Genome Editing</a> convened on Aug. 13 to hash out guidelines about editing human embryos. The goal is to provide a framework that researchers around the globe can consult to ensure their work is in line with scientific consensus.</p>
<p>An earlier U.S. National Academies committee had already released recommendations in 2017. They called for caution – but were ambiguous enough for Chinese scientist He Jiankui to suggest he’d followed them even as he produced <a href="https://theconversation.com/how-a-scientist-says-he-made-a-gene-edited-baby-and-what-health-worries-may-ensue-107764">twin girls with CRISPR-edited genomes</a> late last year.</p>
<p>Here are five stories from our archive that explore how to ethically develop and regulate a potentially risky new technology.</p>
<h2>1. A voluntary pause</h2>
<p>No one denies the power of the CRISPR editing tool. It could allow doctors to one day cure genetic diseases, whether in adults who are living with medical conditions or in embryos that have not yet even been born. But there’s a lot of lab work yet to be done, as well as many conversations to be had, about the right way to proceed.</p>
<p>In 2015, a group of prominent scientists called for a voluntary freeze on germline editing – that is, changing sperm, eggs or embryos – until ethical issues could be resolved.</p>
<p>Chemical biologist <a href="https://theconversation.com/profiles/jeff-bessen-174263">Jeff Bessen</a> wrote that this approach has precedents in the scientific community, where many think it makes sense to take things slow and place “the right emphasis on <a href="https://theconversation.com/crispr-cas-gene-editing-technique-holds-great-promise-but-research-moratorium-makes-sense-pending-further-study-43371">safety and ethics without hampering research progress</a>.”</p>
<h2>2. Stringent hurdles before proceeding</h2>
<p>The National Academies’ 2017 report was meant to provide the scientific community with definitive guidance on the issue.</p>
<p><a href="https://theconversation.com/profiles/rosa-castro-303464">Rosa Castro</a>, a scholar of science and society, explained that the report gave the green light to modifying body cells and a yellow light to modifying reproductive cells that would allow the changes to be inherited by future progeny. The report’s goal was to ensure that “germline genome editing <a href="https://theconversation.com/safe-and-ethical-ways-to-edit-the-human-genome-73110">will be used only</a> to prevent a serious disease, where no reasonable alternatives exist, and under strong supervision.”</p>
<h2>3. Science marches on</h2>
<p>By later that year, a research group announced they’d successfully used CRISPR to modify human embryos, though the edited embryos weren’t implanted in women and were never born. Bioethics and public health professor <a href="https://scholar.google.com/citations?user=eXQqA5gAAAAJ&amp;hl=en&amp;oi=ao">Jessica Berg</a> wrote about the importance of <a href="https://theconversation.com/editing-human-embryos-with-crispr-is-moving-ahead-nows-the-time-to-work-out-the-ethics-81732">working out the ethical issues</a> of gene editing before researchers take the critical step of allowing modified embryos to develop and be born as babies.</p>
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<p>“Should there be limits on the types of things you can edit in an embryo? If so, what should they entail? These questions also involve deciding who gets to set the limits and control access to the technology.</p>
<p>"We may also be concerned about who gets to control the subsequent research using this technology. Should there be state or federal oversight? Keep in mind that we cannot control what happens in other countries.</p>
<p>"Moreover, there are important questions about cost and access.”</p>
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<h2>4. Babies born with edited genomes</h2>
<p>Most of the world reacted with shock in 2018 when a Chinese researcher announced he’d <a href="https://theconversation.com/how-a-scientist-says-he-made-a-gene-edited-baby-and-what-health-worries-may-ensue-107764">edited the germline cells of embryos</a> that went on to become twin baby girls. His stated goal was to protect them from HIV infection.</p>
<p>This development seemed to many researchers to be in violation of at least the spirit of the 2017 guidelines around human gene editing. Biomedical ethicist <a href="https://scholar.google.com/citations?user=yebS-LIAAAAJ&amp;hl=en&amp;oi=ao">G. Owen Schaefer</a> described the central objection: that the procedure was simply too risky, with the potential for unexpected and harmful health effects later in the girls’ lives outweighing any benefit.</p>
<p>He wrote that the “CRISPR babies” are “part of a disturbing pattern in reproduction: <a href="https://theconversation.com/rogue-science-strikes-again-the-case-of-the-first-gene-edited-babies-107684">rogue scientists bucking international norms</a> to engage in ethically and scientifically dubious reproductive research.”</p>
<h2>5. Rules and regs don’t guarantee ethical work</h2>
<p>Whatever the outcome of the current meeting, there may be a distinction between sticking to the rules and doing what’s right. Arizona State professor of life sciences <a href="https://theconversation.com/profiles/j-benjamin-hurlbut-608394">J. Benjamin Hurlbut</a> and applied ethicist <a href="https://scholar.google.com/citations?user=hOM4hNIAAAAJ&amp;hl=en&amp;oi=ao">Jason Scott Robert</a> underscored this point after Chinese scientist He Jiankui claimed he checked off the boxes laid out by the 2017 guidelines.</p>
<blockquote>
<p>“Public debate about the experiment should not make the mistake of <a href="https://theconversation.com/crispr-babies-raise-an-uncomfortable-reality-abiding-by-scientific-standards-doesnt-guarantee-ethical-research-108008">equating ethical oversight with ethical acceptability</a>. Research that follows the rules is not necessarily good by definition.”</p>
</blockquote>
<p>Guidelines and expectations can help define what the scientific community finds acceptable. But complying with the routines of oversight doesn’t guarantee a project is ethical. That’s a much more complicated question.</p>
<p><em>Editor’s note: This story is a roundup of articles from The Conversation’s archives.</em></p><img src="https://counter.theconversation.com/content/121912/count.gif" alt="The Conversation" width="1" height="1" />
CRISPR technology could have momentous effects if it's used to edit genes that will be inherited by future generations. Researchers and ethicists continue to weigh appropriate guidelines.Maggie Villiger, Senior Science + Technology EditorLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1198122019-07-04T04:59:08Z2019-07-04T04:59:08ZWhy the 'molecular scissors' metaphor for understanding CRISPR is misleading<figure><img src="https://images.theconversation.com/files/282579/original/file-20190704-126376-1ak2d64.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">The metaphors we use when we talk about gene editing shape public perception of the complexity involved. </span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/download/confirm/1179311608?src=0QOwip0uEcBP0oDj0keuBw-1-26&amp;studio=1&amp;size=huge_jpg">Shutterstock</a></span></figcaption></figure><p>Last week I read an article about CRISPR, the latest tool scientists are using to edit DNA. It was a great piece – well researched, beautifully written, factually accurate. It covered some of the amazing projects scientist are working on using CRISPR, like bringing animals back from extinction and curing diseases. It also gave me the heebies, but not for the reason you might expect. </p>
<p>My unease was the echo of a feeling I’d had during the early days of my PhD, when some fellow malaria researchers made a discovery that was reported on the news. I was thrilled for them, but I understood the incremental nature of the work they were doing. I knew that in a real-world, drugs-in-the-clinic sense, we were no closer to a breakthrough than we’d been the day before. I thought the reporters had communicated that clearly. Five minutes later my Dad called to ask if I was out of a job, and what I was going to do now that malaria was cured. </p>
<p>I don’t pretend to understand all the myriad reasons for the gaping chasm between what scientists say and what the public hears. Lately though, I’m starting to think it might have something to do with the metaphors we use, and the way they shape our perception of the complexity involved. </p>
<p>Take CRISPR. It’s most often described as a pair of molecular scissors that can be used to modify DNA, the blueprint for life. And when we read that, I think most of us start imagining something like a child with her Lego bricks strewn in front of her, instruction booklet in one hand, scissors in the other. One set of pictograms, one model; one gene, one disease; one snip, one cure. We’re there in a blink. CRISPR seems like it can work miracles. </p>
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<p>I want to stress that the molecular scissors metaphor is pretty damn accurate as far as it goes. But in focusing on the relatively simple relationship between CRISPR and DNA, we miss the far more complicated relationship between DNA and the rest of the body. This metaphor ignores an entire ecosystem of moving parts that are crucial for understanding the awe-inspiring, absolutely insane thing scientists are trying to do when they attempt gene editing. </p>
<h2>I prefer the metaphor of malware</h2>
<p>In my research I use CRISPR from time to time. To design experiments and interpret results effectively, I need a solid way to conceptualise what it can (and can’t) do. I do not think of CRISPR as molecular scissors. </p>
<p>Instead I imagine a city. The greater metropolis represents the body, the suburbs are organs, the buildings are cells, the people are proteins, and the internet is DNA. </p>
<p>In this metaphor CRISPR is malware. More precisely, CRISPR is malware that can search for any chosen 20-character line of code and corrupt it. This is not a perfect metaphor by any stretch, but it gets me closer to understanding than almost anything else.</p>
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<img alt="" src="https://images.theconversation.com/files/282585/original/file-20190704-126345-bfb1b9.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/282585/original/file-20190704-126345-bfb1b9.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=337&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/282585/original/file-20190704-126345-bfb1b9.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=337&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/282585/original/file-20190704-126345-bfb1b9.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=337&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/282585/original/file-20190704-126345-bfb1b9.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=423&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/282585/original/file-20190704-126345-bfb1b9.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=423&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/282585/original/file-20190704-126345-bfb1b9.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=423&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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Read more:
<a href="http://theconversation.com/editing-human-embryos-with-crispr-is-moving-ahead-nows-the-time-to-work-out-the-ethics-81732">Editing human embryos with CRISPR is moving ahead – now's the time to work out the ethics</a>
</strong>
</em>
</p>
<hr>
<h2>Alzheimer’s is like a riot</h2>
<p>As an example, let’s look at Alzheimer’s, one of the diseases CRISPR is being touted to cure. The headlines are usually some variation of “CRISPR to correct Alzheimer’s gene!”, and the molecular scissors analogy is never far behind. </p>
<p>It seems reasonable to me that someone could read those words and assume that chopping away the disease-gene with the DNA-shears should be relatively simple. When the cure doesn’t appear within five years, I can understand why that same person would come to ask me why Big Pharma is holding out (this has happened to me more than once).</p>
<p>Now let’s see how it looks using the malware metaphor. The consensus is that Alzheimer’s manifests when a specific protein goes rogue, causing damage to cells and thereby stopping things from working properly inside the brain. It might have a genetic cause, but it’s complicated. In our allegorical city, what would that look like? </p>
<p>I think riots would come close. Rampaging humans (proteins) destroying houses and property (cells), thereby seriously derailing the normal functioning of a specific suburb (the brain).</p>
<p>And you want to fix that with malware?</p>
<h2>It’s hard to predict the domino effect</h2>
<p>Can you imagine for a second trying to stop soccer hooligans smashing things on the streets of Buenos Aires by corrupting roughly three words in the FIFA by-laws with what’s essentially a jazzed-up command-F function? </p>
<p>I’m not saying it’s not possible – it absolutely is. </p>
<p>But think of all the prior knowledge you need, and all the pieces that have to fall in place for that to work. You’d have to know that the riots are caused by football fans. You’d have to understand which rule was bothering them (heaven help you if it’s more than one), and if that rule causes drama at every game. You’d have to find a 20-character phrase that, when corrupted, would change how the rule was read, rather than just making a trivial typo. </p>
<p>You’d have to know that the relevant footballers have access to the updated rule book, and you’d have to know there were no other regulations making your chosen rule redundant. You’d have to know there aren’t any similar 20-character phrases anywhere on the internet that might get corrupted at the same time (like in the rules for presidential succession say, or in the nuclear warhead codes). Even then you’d still be rolling the dice. </p>
<p>Even if you stop the riots successfully, which of us really know the long-term consequences of changing the World Game forever? </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="http://theconversation.com/these-crispr-modified-crops-dont-count-as-gmos-96002">These CRISPR-modified crops don't count as GMOs</a>
</strong>
</em>
</p>
<hr>
<h2>Reflecting the right level of complexity</h2>
<p>At this point, you might say I’m stretching the metaphor a bit far; that this analogy has become a little stuck up its own behind. You’d not be wrong. </p>
<p>But by thinking the problem this way, we’ve just given ourselves a pretty decent feel for the complications of polygenic disease, incomplete penetrance, missense/nonsense mutations, epigenetic silencing, genetic compensation, off target and germline effects – all without a single word of science jargon. </p>
<p>These are real difficulties scientists are trying to work through to make sure CRISPR is effective and safe. That’s why it takes a long time and costs a lot of money. That’s why most of the promising leads end up going nowhere. </p>
<p>Amazingly, astoundingly, sometimes it works.</p><img src="https://counter.theconversation.com/content/119812/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Elinor Hortle does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The idea of CRISPR as scissors ignores an entire ecosystem of moving parts that are crucial for understanding the awe-inspiring, crazy thing scientists are trying to do when they attempt gene editing.Elinor Hortle, Research Fellow, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1170702019-05-29T12:34:36Z2019-05-29T12:34:36ZGene-edited babies don't grow in test tubes – mothers' roles shouldn't be erased<figure><img src="https://images.theconversation.com/files/276835/original/file-20190528-42580-eeaqjv.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">He Jiankui claims he helped make the world&#39;s first genetically edited babies: twin girls whose DNA he said he altered. </span> <span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Genetic-Frontiers-Gene-Edited-Babies/95551dbf28c24ab086bd60d11c1bcf6b/31/0">AP Photo/Mark Schiefelbein</a></span></figcaption></figure><p><a href="https://www.newscientist.com/article/mg24032073-600-gene-editing-is-so-easy-to-do-that-we-couldnt-stop-it-if-we-wanted-to/">A baby with incandescent green eyes</a>, <a href="https://geneticliteracyproject.org/2018/11/26/crispr-uproar-chinese-researcher-claims-first-gene-edited-babies/">a baby stamped with a bar code</a>, <a href="https://www.technologyreview.com/s/612997/the-crispr-twins-had-their-brains-altered/">another with a glowing gold brain</a>: these are some of the images illustrating stories about the gene-edited twin girls born last November after the world learned of Chinese scientist He Jiankui’s <a href="https://theconversation.com/how-a-scientist-says-he-made-a-gene-edited-baby-and-what-health-worries-may-ensue-107764">controversial efforts to modify embryos</a> with the CRISPR-Cas9 genome editing tool. </p>
<p>The sensational revelation, <a href="https://theconversation.com/the-road-to-enhancement-via-human-gene-editing-is-paved-with-good-intentions-107677">questionable ethics</a> and powerful new technologies of gene editing have made He’s research the subject of ongoing fascination and debate. But strikingly absent in the news has been any discussion of where the embryos developed, how the babies came into the world and who will care for them.</p>
<p>That is to say, their mother. </p>
<p>She is nowhere to be seen in any illustration of the “CRISPR babies,” and news coverage mentions her only in passing. Dubbed the “Chinese Frankenstein,” it is as if the rogue male scientist is the twins’ sole creator.</p>
<p><a href="http://racheladams.net">I am a humanities professor</a> who teaches bioethics, disability and culture, and I find discussion with my students increasingly focused on the implications of rapidly unfolding genetic science. I am also the mother of a child with a genetic disability who reminds me, on a daily basis, that genes are only supporting actors in the complex and wonderful drama of my son’s personhood, and an even more minor backdrop to the ongoing labor of parenting. This means that I have a personal, as well as professional, stake in how genetic knowledge is explained and debated in public.</p>
<p>Ignoring the twins’ mother matters for reasons beyond this individual story. </p>
<p>First, it perpetuates a misunderstanding of science. CRISPR-Cas 9 is a revolutionary technology that allows for quick and precise gene editing, with promising applications in agriculture, pest control and biomedicine. But it also has weighty implications because it can introduce heritable, and potentially irreversible, changes in subsequent generations.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/276831/original/file-20190528-42565-1nl72ou.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/276831/original/file-20190528-42565-1nl72ou.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/276831/original/file-20190528-42565-1nl72ou.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/276831/original/file-20190528-42565-1nl72ou.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/276831/original/file-20190528-42565-1nl72ou.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/276831/original/file-20190528-42565-1nl72ou.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/276831/original/file-20190528-42565-1nl72ou.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/276831/original/file-20190528-42565-1nl72ou.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Zhou Xiaoqin, left, and Qin Jinzhou, an embryologist, part of the team working with scientist He Jiankui, view a time lapse image of embryos on a computer screen at a lab in Shenzhen in southern China’s Guandong province.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/China-Gene-Edited-Babies/a1b252903c424acf9609c03467a2fa6e/39/0">AP Photo/Mark Schiefelbein</a></span>
</figcaption>
</figure>
<h2>The myth of the test tube babies</h2>
<p>Of course, there are good reasons to conceal the mother’s identity. He claimed his study was for HIV research and prevention and recruited couples with an HIV-positive male partner and an uninfected female. Such couples were promised fertility treatments in exchange for their participation. Intense stigmas around both HIV and infertility in China are good reason to shroud both parents in secrecy. </p>
<p>Another is the controversial nature of He’s research and the deliberately spectacular way he chose to reveal it. Obscuring the mother’s identity protects her privacy, shielding her family from unwanted and largely negative publicity raging around the experiment. But there is a difference between protecting a person’s identity and obscuring her story. What does the virtual invisibility of a maternal presence say about the twins’ conception, birth and future well-being? </p>
<p>As in Mary Shelley’s “Frankenstein” and any number of later science fiction narratives, it is as if the babies were not only conceived but developed in a laboratory. It is as if the actual woman whose uterus nurtured their bodies, whose flesh was cut open and sutured to ensure their safe delivery (assuming they were born by C-section, as are many twins), whose breasts are making milk to nourish them, didn’t exist at all. As if, like Shelley’s misguided doctor, He is the babies’ sole creator.</p>
<p>In fact, now that the babies are born, their mother is surely their primary caregiver. Regardless of how her twins were conceived, she is responsible for their well-being and development. Like other new mothers, she has doubtless experienced wakeful nights, breasts leaking milk, countless dirty diapers. By now she has probably seen her babies smile, roll over, babble and play with toys. But these more pedestrian experiences of motherhood must also be intermingled with constant media, scientific and governmental scrutiny of her children and the processes that brought them into being. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/276837/original/file-20190528-42584-1w7yrla.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/276837/original/file-20190528-42584-1w7yrla.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/276837/original/file-20190528-42584-1w7yrla.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/276837/original/file-20190528-42584-1w7yrla.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/276837/original/file-20190528-42584-1w7yrla.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/276837/original/file-20190528-42584-1w7yrla.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/276837/original/file-20190528-42584-1w7yrla.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/276837/original/file-20190528-42584-1w7yrla.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A depiction of Dr. Frankenstein and his creation in a wax museum in Barcelona.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/barcelona-spain-aug-11-2018-doctor-1159963069?src=oI_hAudiDrfBUnqUx0GmjA-1-51">Anton_Ivanov</a></span>
</figcaption>
</figure>
<h2>The hidden labor of care</h2>
<p>The twins’ mother must be aware her babies face uncertain health outcomes as a result of their edited genes. He claimed he was trying to protect the girls from HIV. By <a href="http://doi.org/10.1038/d41586-018-07573-w">all accounts</a>, the couple was misled about the nature of He’s research, meaning that they could not have given fully informed consent. </p>
<p>As part of the consent agreement, He’s team had promised to oversee the twins’ medical needs until age 18. But now that the scientist has <a href="http://time.com/5469111/he-jiankui-scientist-missing-gene-edited-babies/">disappeared</a> and his <a href="https://www.apnews.com/0be63430c5914f09a124b968c844d994">lab disbanded</a>, it is unclear who will provide them with health care. </p>
<p>CRISPR does not bypass the role of mothers in species reproduction and care. He is a Dr. Frankenstein in the recklessness of his methods, but not because he has managed to supersede the biological functions of the female body or the contribution of mothers (biological or not) to a child’s development. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/276848/original/file-20190528-42580-1d5kgwx.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/276848/original/file-20190528-42580-1d5kgwx.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/276848/original/file-20190528-42580-1d5kgwx.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/276848/original/file-20190528-42580-1d5kgwx.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/276848/original/file-20190528-42580-1d5kgwx.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/276848/original/file-20190528-42580-1d5kgwx.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/276848/original/file-20190528-42580-1d5kgwx.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">No genetic technology eliminates the mother’s role.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/portrait-woman-relaxing-home-her-little-512079628?src=TtMKlfeLNhjlohddWKwrjA-1-29">pixelheadphoto digitalskillet/Shutterstock.com</a></span>
</figcaption>
</figure>
<h2>The politics of maternal invisibility</h2>
<p>Like other new reproductive technologies, from ultrasound to amniocentesis and IVF, CRISPR is likely to present pregnant women with more responsibilities and decisions, not remove them from the process. At a time when leading scientists and bioethicists are calling for widespread and informed civic debate about the future of genomic research, it is essential to foster, rather than obscure, public understanding of basic genetic science.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/276841/original/file-20190528-42588-1xojlpf.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/276841/original/file-20190528-42588-1xojlpf.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/276841/original/file-20190528-42588-1xojlpf.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=652&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/276841/original/file-20190528-42588-1xojlpf.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=652&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/276841/original/file-20190528-42588-1xojlpf.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=652&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/276841/original/file-20190528-42588-1xojlpf.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=820&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/276841/original/file-20190528-42588-1xojlpf.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=820&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/276841/original/file-20190528-42588-1xojlpf.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=820&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Excluding the mother from talk about gene editing created the impression that the mother is now obsolete.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-vector/genetic-engineering-vitro-fertilization-eps-8-1230974200?src=ENuyRzFDhQbVzA4lEBm-Yg-1-13">Aleutie</a></span>
</figcaption>
</figure>
<p>The invisibility of the mother’s body in images of the CRISPR babies also makes a political statement. The picture of a <a href="https://www.telegraph.co.uk/family/parenting/designer-babies-far-should-science-go-create-perfect-human/">fetus growing</a> <a href="https://theconversation.com/those-designer-babies-everyone-is-freaking-out-about-its-not-likely-to-happen-103079">in a test tube</a> or a free-floating womb is not just the stuff of science fiction, but has also been widely used in anti-abortion arguments. By representing the fetus as if it were a baby capable of independent life, opponents of reproductive freedom have claimed it has rights that take priority over those of the woman who sustains it. This is the logic at work behind <a href="https://www.nytimes.com/aponline/2019/05/20/us/ap-us-abortion-alabama.html?searchResultPosition=10">recent laws passed in Alabama</a> and other states that restrict abortion once a fetal heartbeat is detected, even if the pregnancy resulted from rape or incest. Regardless of He’s own politics, representations of the CRISPR babies contribute to deprioritizing maternal health and autonomy, as well as the ongoing work of mothering.</p>
<p>CRISPR is a revolutionary technology whose applications should be thoroughly debated by stakeholders at all levels of society. But nowhere does the new science propose to replace the female body or the role of mothers in a child’s care and well-being. It is time to edit the stories we tell about gene editing. We can preserve the privacy of the mother of Lulu and Nana while also acknowledging her place in any consideration of their future, and the future life of the species.</p><img src="https://counter.theconversation.com/content/117070/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Rachel Adams does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>News of the gene-edited babies excludes images of the children's mother. Cutting her out of the picture underscores the idea that the mother is obsolete and babies can be created in the lab.Rachel Adams, Professor of English and Comparative Literature, Columbia UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1162832019-04-30T22:24:42Z2019-04-30T22:24:42ZHow we used CRISPR to narrow in on a possible antidote to box jellyfish venom<figure><img src="https://images.theconversation.com/files/271864/original/file-20190430-136800-u6bay2.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Venom from box jellyfish causes extreme pain and tissue damage. Massive exposure can cause death. </span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/box-jellyfish-lesion-on-child-leg-488958124?src=nm9W0vMB1jI5XWj42eHEmQ-1-9">from www.shutterstock.com</a></span></figcaption></figure><p>Warm Australian waters are home to the box jellyfish (<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3773479/"><em>Chironex fleckeri</em></a>), which is considered to be one of the most venomous animals on the planet. </p>
<p>Box jellyfish stings lead to excruciating pain lasting days, tissue death and scarring at the site of the sting, and with significant exposure, death within minutes. While most jellyfish stings do not lead to death, pain and scarring is quite common.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="http://theconversation.com/why-we-dont-know-if-irukandji-jellyfish-are-moving-south-109653">Why we don't know if Irukandji jellyfish are moving south</a>
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<p>Despite its potent ability to cause pain and death, to date we’ve had very little understanding of <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3773479/">how this deadly venom works</a>. This makes it very difficult to understand how it can cause so much pain – and how to develop medicines to block venom actions.</p>
<p>Published today, our <a href="https://www.nature.com/articles/s41467-019-09681-1">new research</a> has uncovered a potential antidote for box jellyfish venom. By working with humans cells and the gene-editing tool CRISPR, we identified a common, cheap drug that is already on the market and which could be a candidate for treating box jellyfish stings. </p>
<h2>Flipping all the switches</h2>
<p>This work began in 2012, when we set out to determine what it was about box jellyfish venom molecules that made them so effective in causing pain and damage. </p>
<p>The venom didn’t seem to work through the known pathways that cause cell death. So we used <a href="https://theconversation.com/what-is-crispr-gene-editing-and-how-does-it-work-84591">CRISPR</a> genome editing technologies in human cells grown in the laboratory. This let us systematically turn off each gene in the human genome, and test to see which of these is needed for the jellyfish venom to kill the cells. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="http://theconversation.com/what-is-crispr-gene-editing-and-how-does-it-work-84591">What is CRISPR gene editing, and how does it work?</a>
</strong>
</em>
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<hr>
<p>It’s kind of like flipping all the switches in a house, trying to figure out which one turns off the kitchen lights, but at the whole genome level. We actually didn’t even know if it would be possible to find single genes that when turned off could block the venom action.</p>
<p>But luckily, we were successful. While normal human cells exposed to venom die in the laboratory within five minutes, we identified gene-edited cells that could last for two weeks continually exposed to venom.</p>
<h2>Putting the evidence together</h2>
<p>Then using new DNA sequencing technologies (that allow us to identify CRISPR guide RNAs targeting specific genes), we identified which human genes had been switched off in our genome editing experiments.</p>
<p>By putting the evidence together, we worked out which genes the box jellyfish venom needs to target in order to kill human cells in the lab.</p>
<p>One we identified is a calcium transporter molecule called ATP2B1, and is present on the surface of cells. </p>
<p>We tested a drug that we know targets this gene. If we added the drug before the venom, we could block cell death, but if we added the drug after the venom, it didn’t have any effect. </p>
<p>So this helped us understand more about how the venom works – and maybe even how it causes pain. We are still looking at this particular pathway in more detail, but at the moment it doesn’t seem promising for a therapy.</p>
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Read more:
<a href="http://theconversation.com/going-to-the-beach-this-easter-here-are-four-ways-were-not-being-properly-protected-from-jellyfish-112955">Going to the beach this Easter? Here are four ways we're not being properly protected from jellyfish</a>
</strong>
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<h2>Stopping cell death</h2>
<p>Next we looked at the pathways involved in <em>how</em> box jellyfish venom kills cells. </p>
<p>We found four of the top ten genes required for venom action were all part of a pathway that makes cholesterol in cells. </p>
<p>Since cholesterol has been heavily studied over the last 30 years, there are already drugs available that target lots of different steps in cholesterol regulation. We focused on drugs that could bind to cholesterol and remove it quickly, basically acting like a cholesterol sponge.</p>
<p>We found these drugs could completely block the box jelly fish venom’s ability to kill human cells in the lab if added before venom exposure. We also found there is a 15-minute window after venom exposure where if we add this cholesterol sponge, it still blocks venom action. </p>
<p>This was exciting, as the capacity to have effect after the venom means the drug could work as a treatment in the case of being stung by a box jellyfish. </p>
<p>So far our additional studies show that these same drugs can block pain, tissue death and scarring associated with a mouse model of box jellyfish stings. </p>
<h2>Moving towards a human treatment</h2>
<p>The really cool thing about this work is that the potential box jellyfish antidote we found is in a family of drugs called <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6273856/">cyclodextrins</a>. These are known to be safe for us in humans, and are cheap and stable. </p>
<p>So now we are trying to work with the state or national government, or first responders, to see if we can move this venom antidote forward for human use.</p>
<p>As well as developing a topical application at the site of a sting, we also aim to develop this idea as a potential treatment for cardiac injection in the emergency room in the case of very severe box jellyfish sting cases.</p><img src="https://counter.theconversation.com/content/116283/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Greg Neely receives funding from the NHMRC and Cancer Council NSW. </span></em></p>Box jellyfish stings are excruciating and occasionally deadly. We have identified a common, cheap drug that is already on the market and which could be a treatment candidate with further development.Greg Neely, Associate Professor , University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1133382019-03-21T10:46:21Z2019-03-21T10:46:21ZWill more genetically engineered foods be approved under the FDA's new leadership?<figure><img src="https://images.theconversation.com/files/264654/original/file-20190319-60964-tkeko6.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Will food laws change as more GM foods are created?</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/law-book-gavel-food-393936415">Zerbor/Shutterstock.com</a></span></figcaption></figure><p>The world of food and drug regulation was rocked earlier this month by the news of a change in leadership at the Food and Drug Administration. Commissioner Scott Gottlieb <a href="https://www.npr.org/sections/health-shots/2019/03/05/700482545/fda-commissioner-scott-gottlieb-announces-he-will-resign">resigned</a> and will step down in early April. His <a href="https://www.nytimes.com/2019/03/12/health/fda-ned-sharpless.html">temporary replacement</a> is <a href="https://www.cancer.gov/about-nci/leadership/director">Dr. Ned Sharpless</a>, director of the National Cancer Institute. </p>
<p>As the news filtered out, stocks went <a href="https://www.thestreet.com/investing/scott-gottlieb-s-exit-has-tobacco-stocks-rising-tuesday-14887017">up</a> and <a href="https://www.thestreet.com/investing/stocks/tobacco-stocks-drop-after-new-acting-fda-commissioner-is-named-14894403">down</a>, consumer advocacy groups <a href="https://www.nclnet.org/scott_gottlieb_resigns">looked back</a> on Gottlieb’s legacy and commentators <a href="https://www.vox.com/policy-and-politics/2019/3/5/18252139/scott-gottlieb-resigns-fda-opioid-epidemic">worried</a> about the future of the agency.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/264645/original/file-20190319-60975-5iveto.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/264645/original/file-20190319-60975-5iveto.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/264645/original/file-20190319-60975-5iveto.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=498&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/264645/original/file-20190319-60975-5iveto.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=498&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/264645/original/file-20190319-60975-5iveto.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=498&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/264645/original/file-20190319-60975-5iveto.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=626&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/264645/original/file-20190319-60975-5iveto.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=626&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/264645/original/file-20190319-60975-5iveto.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=626&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">FDA Commissioner Dr. Scott Gottlieb will leave the post in early April.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/washington-dc-november-3-2017-fda-751933783">Albert H. Teich/Shutterstock.com</a></span>
</figcaption>
</figure>
<p>Most of the attention surrounding Gottlieb’s departure has focused on the consequences of the resignation for the <a href="https://www.cnbc.com/2019/03/10/fda-chiefs-departure-might-not-be-a-good-thing-for-vaping-industry.html">vaping and tobacco</a> industries. But the impact of changes in FDA leadership extends well beyond that. FDA-regulated products make up <a href="https://www.fda.gov/AboutFDA/Transparency/Basics/ucm553038.htm">20 percent of consumer spending</a> in the U.S. In the realm of food alone, FDA regulates <a href="https://www.fda.gov/AboutFDA/Transparency/Basics/ucm553038.htm">75 percent of our food supply</a>. </p>
<p>As a <a href="https://papers.ssrn.com/sol3/cf_dev/AbsByAuth.cfm?per_id=2667484">professor</a> who studies FDA and health law at Saint Louis University, I have been working with the <a href="https://www.slu.edu/law/health/index.php">Center for Health Law Studies</a> to monitor changes in FDA regulations and policies. Most recently I’ve been tracking progress on the FDA’s regulation of genetically modified food and think I can explain what consumers can expect from the agency after Gottlieb departs.</p>
<h2>How the FDA deals with GM plants and animals</h2>
<p>Genetically modified plants <a href="https://www.fda.gov/food/ingredientspackaginglabeling/geplants/ucm346030.htm">entered the U.S. market</a> in the 1990s. Since then, the official FDA position has been that food derived from genetically modified plants and animals is <a href="https://www.fda.gov/Food/IngredientsPackagingLabeling/GEPlants/ucm346858.htm">not different</a> “from other foods in any meaningful or uniform way.” This includes considerations regarding safety and long-time effects associated with its consumption. </p>
<p>Many people regard genetically modified food as a means to feed more people at a lower cost. However, recent studies suggest that these promises remain <a href="https://www.technologyreview.com/s/522596/why-we-will-need-genetically-modified-foods/">unfulfilled</a> since genetically engineered food first became available in the 1990s.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/264662/original/file-20190319-60972-12q744j.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/264662/original/file-20190319-60972-12q744j.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/264662/original/file-20190319-60972-12q744j.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=450&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/264662/original/file-20190319-60972-12q744j.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=450&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/264662/original/file-20190319-60972-12q744j.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=450&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/264662/original/file-20190319-60972-12q744j.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=566&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/264662/original/file-20190319-60972-12q744j.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=566&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/264662/original/file-20190319-60972-12q744j.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=566&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">The Chinook salmon during spawning.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/closeup-chinook-salmon-during-spawning-1212401593">Kevin Cass/Shutterstock.com</a></span>
</figcaption>
</figure>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/264660/original/file-20190319-60964-s2kst.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/264660/original/file-20190319-60964-s2kst.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/264660/original/file-20190319-60964-s2kst.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=386&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/264660/original/file-20190319-60964-s2kst.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=386&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/264660/original/file-20190319-60964-s2kst.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=386&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/264660/original/file-20190319-60964-s2kst.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=485&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/264660/original/file-20190319-60964-s2kst.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=485&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/264660/original/file-20190319-60964-s2kst.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=485&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Ocean pout from Newfoundland, Canada.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/dkeats/5532424100/">Derek Keats</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>Even though scientists have been able to alter the genome of animals for decades, it was not until 2008 that the FDA <a href="https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/BiotechnologyProductsatCVMAnimalsandAnimalFood/AnimalswithIntentionalGenomicAlterations/ucm113605.htm">issued guidance</a> on genetically modified animals. Since then, the agency has become much more active in this area. In 2017, months before Gottlieb became commissioner, the FDA issued <a href="https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/BiotechnologyProductsatCVMAnimalsandAnimalFood/AnimalswithIntentionalGenomicAlterations/ucm113605.htm">further guidance</a> on the use of emerging technologies, like <a href="https://www.pbs.org/wgbh/nova/article/crispr-animals/">CRISPR</a>, that allow scientists to alter animal genomes.</p>
<p>As with plants, the FDA considers genetically engineered animals safe for human consumption. The agency <a href="https://www.fda.gov/animalveterinary/developmentapprovalprocess/newanimaldrugapplications/default.htm">reviews</a> these types of products as new animal drug applications. </p>
<p>In 2015, two years before Gottlieb began his tenure, the FDA <a href="https://www.fda.gov/downloads/AnimalVeterinary/DevelopmentApprovalProcess/BiotechnologyProductsatCVMAnimalsandAnimalFood/AnimalswithIntentionalGenomicAlterations/UCM466218.pdf">favorably reviewed</a> an application involving <a href="https://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/BiotechnologyProductsatCVMAnimalsandAnimalFood/AnimalswithIntentionalGenomicAlterations/ucm473238.htm">AquAdvantage salmon.</a> Although AquAdvantage salmon was being produced in Canada in 2016, Congress directed FDA to restrict importation of AquAdvantage salmon into the United States. This genetically modified fish incorporates a growth hormone <a href="https://newfoodeconomy.org/fda-aquabounty-gmo-salmon-seafood-restriction-market/">gene</a> from Chinook salmon and links it to a genetic switch, or promoter. The promoter taken from an eel-like fish called ocean pout keeps the growth hormone gene in the “on” position, allowing it to grow significantly faster than comparable Atlantic salmon. </p>
<h2>Gottlieb’s FDA and regulation of GE food</h2>
<p>Also in 2016, Congress made the U.S. Department of Agriculture the <a href="https://www.usda.gov/media/press-releases/2018/12/20/establishing-national-bioengineered-food-disclosure-standard">leading player</a> in the labeling of genetically engineered food. The USDA issued final <a href="https://www.federalregister.gov/documents/2018/12/21/2018-27283/national-bioengineered-food-disclosure-standard">regulations</a> on this topic in late 2018. </p>
<p>As a response, on March 8, 2019, Gottlieb’s FDA <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632952.htm">reversed</a> the regulation prohibiting the importation of AquAdvantage salmon. With this decision, FDA underscored the agency’s belief that the product is safe for humans.</p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/264716/original/file-20190319-60949-tfaxip.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/264716/original/file-20190319-60949-tfaxip.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/264716/original/file-20190319-60949-tfaxip.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=600&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/264716/original/file-20190319-60949-tfaxip.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=600&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/264716/original/file-20190319-60949-tfaxip.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=600&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/264716/original/file-20190319-60949-tfaxip.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=754&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/264716/original/file-20190319-60949-tfaxip.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=754&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/264716/original/file-20190319-60949-tfaxip.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=754&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Both the U.S. FDA and the World Health Organization have declared genetically modified crops and engineered food safe.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/genetically-modified-crops-engineered-food-agriculture-295120262">Lightspring/Shutterstock.com</a></span>
</figcaption>
</figure>
<p>In addition to endorsing the general safety of genetically engineered foods, Gottlieb’s official statement highlights the FDA’s goal of explicitly <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm632952.htm">assuring consumers</a> that genetically engineered foods available in the United States market “meet the FDA’s high safety standards.”</p>
<p>In many ways, the response of the agency can be seen as purely mechanical and deferential to USDA and Congress. But I think it also signals continuity of a permissive policy when it comes to genetically engineered food. By treating it the same way it treats traditional food, the FDA will intervene if genetically engineered food is contaminated or prepared under unsanitary conditions, as it normally does under its general mandate as an agency tasked with protecting the public health. </p>
<p>But we should not expect FDA to challenge the <a href="https://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/">prevailing wisdom</a> among <a href="https://royalsociety.org/topics-policy/projects/gm-plants/how-are-gm-crops-regulated/">regulatory agencies</a> when it comes to genetically modified food.</p>
<p>The FDA’s behavior in this field is in line with the current scientific consensus in the <a href="http://nas-sites.org/ge-crops/">United States</a> and <a href="https://royalsociety.org/topics-policy/projects/gm-plants/">abroad</a>. Numerous reputable institutions have upheld the safety of genetically engineered food. These include the <a href="https://www.sciencemag.org/news/2016/05/once-again-us-expert-panel-says-genetically-engineered-crops-are-safe-eat">National Academy of Sciences</a> and the <a href="https://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/">World Health Organization</a>. Nevertheless, there are some critics of this consensus who call for <a href="https://www.scientificamerican.com/article/the-truth-about-genetically-modified-food/">more research</a> into the long-term effects of eating genetically modified food. According to recent data, consumers <a href="https://www.nytimes.com/2018/04/23/well/eat/are-gmo-foods-safe.html">continue to distrust</a> genetically engineered food as well.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/264718/original/file-20190319-60949-1p4e9cy.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/264718/original/file-20190319-60949-1p4e9cy.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/264718/original/file-20190319-60949-1p4e9cy.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/264718/original/file-20190319-60949-1p4e9cy.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/264718/original/file-20190319-60949-1p4e9cy.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/264718/original/file-20190319-60949-1p4e9cy.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/264718/original/file-20190319-60949-1p4e9cy.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Social justice activists staged a rally in Lafayette Park across from the White House and then marched to Monsanto’s Washington offices.</span>
<span class="attribution"><a class="source" href="https://www.flickr.com/photos/stephenmelkisethian/14238580036/in/photolist-nGdrMf-dnoFgn-gvETVj-gr7dUZ-gvExKt-gvDXqK-26unk3Q-gvCYW3-gAtxC4-gvEQFy-gvDTwW-gAk9DK-gr7ega-gADipA-nJdjQB-etV6fy-8Fh1KR-8FjXfQ-nrPTPX-9XXYqx-gArj2b-gDY6Fa-nHXVNi-gBgbPk-gBgceE-nGypqS-gDXngj-gAtq9M-nrWUEU-gBSEdu-nJAToD-gBTcPT-gDXMBz-nJ69dW-gDWUxm-fzCmt6-gArPWH-gBThfr-gBTbxK-gBgaYH-gAjSoP-bkHahh-ngQvxa-gjKT9c-gAjgvp-gAjW3A-gAk3VR-gBTixr-3oABp-65sLVL">Stephen Melkisethian/Flickr</a>, <a class="license" href="http://creativecommons.org/licenses/by-nc-nd/4.0/">CC BY-NC-ND</a></span>
</figcaption>
</figure>
<h2>GM food under Sharpless and beyond</h2>
<p>I believe that in the near future, FDA will address this distrust while continuing to guide the industry as different types of genetically engineered food enter the market.</p>
<p>Right now, we know virtually nothing about the views of the incoming acting commissioner on genetically engineered food, or food regulation in general. I think the most likely scenario is that Sharpless’ FDA will not stray from its current path regarding genetically engineered food. In 2018, Gottlieb launched a <a href="https://www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm624490.htm">Plant and Animal Biotechnology Innovation Action Plan</a>, describing a public communication strategy to engage stakeholders. The plan includes public webinars on animal genome editing, as well as guidance on plant and animal biotechnology. Given the current scientific consensus, it would be surprising if Sharpless chose to move the agency in a different direction. </p>
<p>On the labeling front, now that FDA has relinquished most of its authority in this matter to the USDA, the debate is likely to shift elsewhere. Already under Gottlieb, much energy was spent on <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm621824.htm">labeling issues</a> involving almond milk and vegan cheese. The agency worried that using dairy names to described plant-based products might be confusing to consumers.</p>
<p>It is of course possible that Sharpless will not be at the helm of FDA for very long. After all, he is an interim figure of <a href="https://www.sciencemag.org/news/2017/06/trump-names-sharpless-lead-us-cancer-institute?r3f_986=https://www.google.com/">Democratic leanings</a>. However, given FDA’s <a href="https://endpts.com/how-do-you-replace-a-rock-star-like-scott-gottlieb-at-the-fda-maybe-you-dont/">improbable</a> recent history, there is reason to expect some institutional continuity in the foreseeable future.</p>
<p>Consumers should therefore count on increasing numbers of genetically modified plants and animals entering our food supply. Absent a change in scientific consensus, FDA will smooth the pathway for companies to bring these products to market.</p><img src="https://counter.theconversation.com/content/113338/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Ana Santos Rutschman ne travaille pas, ne conseille pas, ne possède pas de parts, ne reçoit pas de fonds d&#39;une organisation qui pourrait tirer profit de cet article, et n&#39;a déclaré aucune autre affiliation que son poste universitaire.</span></em></p>With Gottlieb's departure from the FDA imminent, what should we expect from the FDA? How is it likely to regulate the still controversial genetically engineered foods?Ana Santos Rutschman, Assistant Professor of Law, Saint Louis UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1136392019-03-15T19:44:58Z2019-03-15T19:44:58ZCRISPR gene editing: Why we need Slow Science<figure><img src="https://images.theconversation.com/files/264022/original/file-20190314-28468-1v3lii1.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Experts have called for a moratorium on clinical research with CRISPR/Cas9 gene editing
of the germline — that is changing heritable DNA in sperm, eggs or embryos to make genetically modified children. </span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>In a <a href="https://www.nature.com/articles/d41586-019-00726-5">newly published article in <em>Nature</em></a>, a group of prominent scientists and ethicists have called for a moratorium on clinical research using <a href="https://theconversation.com/what-is-crispr-gene-editing-and-how-does-it-work-84591">CRISPR/Cas9 gene editing</a>. </p>
<p>This moratorium deals with the use of CRISPR/Cas9 gene editing of the germline — changing heritable DNA in sperm, eggs or embryos to make genetically modified children. </p>
<p>In other words, this would be a temporary ban on experiments that <a href="https://theconversation.com/why-we-are-not-ready-for-genetically-designed-babies-107756">might result in more “CRISPR babies.”</a></p>
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<a href="http://theconversation.com/opening-pandoras-box-gene-editing-and-its-consequences-108003">Opening Pandora's Box: Gene editing and its consequences</a>
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<p>The document was signed and authored by a number of prominent ethicists and scientists, including CRISPR pioneers <a href="https://www.emmanuelle-charpentier-lab.org/our-team/emmanuelle-charpentier/">Emmanuelle Charpentier</a> (one of the co-discovers of the CRISPR/Cas9) and <a href="https://zlab.bio">Feng Zhang</a> (one of the first to use CRISPR in human cells), as well as <a href="https://www.broadinstitute.org/bios/eric-s-lander">geneticist Eric Lander</a> and bioethicists <a href="https://www.dal.ca/sites/noveltechethics/our-people/francoise-baylis.html">Françoise Baylis</a> and <a href="https://www.otago.ac.nz/bioethics/people/academic/profile/?id=665">Jing-Bao Nie</a>. </p>
<p>However, CRISPR researcher Jennifer Doudna (the other co-discoverer of the CRISPR/Cas9 system) refused to sign this call for a moratorium. She told <a href="https://www.washingtonpost.com/science/2019/03/13/nih-top-scientists-call-moratorium-gene-edited-babies/?noredirect=on&amp;utm_term=.c452381d4f8a"><em>The Washington Post</em></a>: “My feeling is, this is effectively just rehashing what’s been going on for several years.” </p>
<p>This is a contentious point, as the word moratorium has been used sparsely by the scientists involved in this research. Many of the signatories have, however, been vocal about <a href="https://www.broadinstitute.org/bios/david-liu">their views</a> on <a href="https://www.nejm.org/doi/full/10.1056/NEJMp1506446">germline gene editing</a> in the past. </p>
<p>By asking for a global moratorium, the signatories do not mean a permanent ban, but rather, a temporary one — to allow for the development of an international governance framework surrounding <a href="https://www.geneticsandsociety.org/internal-content/about-human-germline-gene-editing">human germline genome editing</a>. Specifically, they suggest a five-year moratorium, a period of time sufficient to allow critical conversations and stakeholder engagement. </p>
<p>Importantly, they are not calling for a unanimous decision among nations either. Countries would be allowed to come up with their own regulatory framework considering the ethical, scientific, technical and medical considerations of CRISPR/Cas9 germline gene editing.</p>
<h2>Slowing down science for the common good</h2>
<p>CRISPR/Cas9 gene editing has moved forward at unprecedented speed since CRISPR was first used in human cells in vitro in 2013 to claims of the birth of the <a href="https://www.sciencenews.org/article/gene-edited-babies-top-science-stories-2018-yir">first germline gene-edited babies in 2018</a>. This is very concerning, especially when the medical need and social risks are still being debated and the safety and efficacy of the treatments are still largely unknown.</p>
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<p>In our view, what the authors of the recent <em>Nature</em> editorial are asking for is Slow CRISPR Science. <a href="http://slow-science.org/">Slow Science</a> — a response to the increasing speed and corporate interest driving the scientific endeavour, and the “publish or perish paradigm” — was built on concepts of the <a href="https://www.slowfood.com/">Slow Food</a> movement. </p>
<p>Slow Food was a direct response to Fast Food, a system in which the environment, people and economies were often jeopardized at the expense of corporate interests that ostensibly provided quick and easy meals. Ideally, the Slow movement is not calling for “less productivity or efficiency” but for more thoughtful and engaging work be done in the food industry and in science.</p>
<p>In terms of gene editing, moving slow would mean perfecting non-heritable gene-editing techniques in patients before attempting ethically charged and technically more difficult heritable gene-editing clinical trials (which appear to be driven by profit or the need to be first, rather than societal need or the common good).</p>
<p>J. Benjamin Hurlbut, an associate professor of biology and society at Arizona State University, wrote in a <a href="https://www.nature.com/articles/d41586-018-07881-1"><em>Nature</em> commentary</a> in early January 2019: </p>
<blockquote>
<p>“To move forward in a positive direction, science must not presume to set the destination for a technology, but should follow the direction that we, the people, provide.”</p>
</blockquote>
<p>Slow CRISPR science would allow for proper consultation with appropriate stakeholders and the public before making the decision to move forward.</p>
<h2>A divided scientific community</h2>
<p>Scientific communities are not in agreement on the issue of a moratorium. In fact, a commentary published in <em>Science</em> in 2015 pushed for “<a href="http://science.sciencemag.org/content/348/6230/36">a prudent path forward</a>” and discussed what steps should be taken to ensure ethical and safe use of this technology. </p>
<p>However, the word <em>moratorium</em> was never used in this document. Further, many of the authors of the 2015 publication have shied away from a moratorium, with much of the organizing committee of the <a href="http://www.nationalacademies.org/hk/">2018 Human Genome Editing Summit</a> (many of whom were also authors on the 2015 <em>Science</em> article) <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11282018b">suggesting a “translational pathway”</a> on human germline genome editing. </p>
<p>This is in direct conflict with the language in the concluding statement of the 2015 Human Gene Editing Summit that considered germline genome editing “<a href="https://www.nap.edu/read/21913/chapter/1#6">irresponsible</a>” until relevant safety and efficacy concerns were addressed and “broad societal consensus” was achieved.</p>
<p>Many have effectively skipped to the question of, “How we can do this,” rather than, “Should we do this?” </p>
<p>Ultimately a period of time to pause and reflect would allow for citizens in each nation to have the important conversation of whether their society condones germline genome editing. Each society has to decide for themselves if the rewards outweigh the risks, informed by science but not dictated by it.</p>
<h2>Time to get it right</h2>
<p>For Canada, the moratorium will have little effect on CRISPR research activity as germline gene editing of embryos is already banned under the <a href="https://laws-lois.justice.gc.ca/eng/acts/a-13.4/">2004 Assisted Human Reproduction Act</a>. </p>
<p>Clearly the stakes are high, and missteps in the early applications of CRISPR to human health may result in an all-out ban on this technology, which holds such incredible promise for alleviating human suffering by curing genetic disease. </p>
<p>Therefore, a prudent step in our view is to temporarily press pause on germline gene editing to allow deeper contemplation of the risks and benefits. In essence, this is what these scientists and ethicists are calling for in their proposed moratorium. </p>
<p>They are requesting time to pause and reflect. Time to conduct the appropriate consultations with relevant stakeholders, and (very importantly) the public in an attempt to achieve broad societal consensus. And finally, time to develop the most robust and precise gene-editing tools so that when we use CRISPR/Cas9 to rewrite the source code of humanity, we get it right.</p>
<p><em>This is a corrected version of a story originally published March 15, 2019. The earlier story misattributed a quote calling for “broad scientific consensus” on human germline genome editing. The quote has been removed from the corrected version.</em></p><img src="https://counter.theconversation.com/content/113639/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Landon J Getz receives funding from the Natural Sciences and Engineering Research Council of Canada. </span></em></p><p class="fine-print"><em><span>Graham Dellaire receives funding from the Canadian Institutes of Health Research (CIHR). </span></em></p>CRISPR gene editing should learn from the Slow Food movement. Scientists must allow time for critical conversations and perfecting of techniques before rewriting the source code of humanity.Landon J Getz, Ph.D. Candidate in Microbiology and Immunology, Dalhousie UniversityGraham Dellaire, Director of Research and Professor of Pathology, Dalhousie UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1134632019-03-13T19:11:18Z2019-03-13T19:11:18ZExperts call for halt to CRISPR editing that allows gene changes to pass on to children<figure><img src="https://images.theconversation.com/files/263553/original/file-20190313-86713-uwtcri.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">CRISPR is a gene editing tool that can create permanent changes in the human genome. </span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/newborn-baby-first-many-small-hospital-1103569475">from www.shutterstock.com</a></span></figcaption></figure><p>Remember the global outrage four months ago at world-first claims a researcher had used the gene editing tool CRISPR to <a href="https://theconversation.com/researcher-claims-crispr-edited-twins-are-born-how-will-science-respond-107693">edit the genomes of twin girls</a>? </p>
<p>The molecular scissors known as CRISPR (<a href="https://theconversation.com/what-is-crispr-gene-editing-and-how-does-it-work-84591">CRISPR/cas9</a> in full) allow scientists to modify DNA with high precision and greater ease than previous technologies.</p>
<p>Now researchers from the USA, Europe, China and New Zealand have published a prominent call for <a href="https://www.nature.com/articles/d41586-019-00726-5">a moratorium</a>, or temporary freeze, on the clinical use of germline gene editing technology in humans. (Germline editing means the genes that are edited are included in eggs and sperm, the “germ” cells, and can be passed on to following generations). </p>
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Read more:
<a href="http://theconversation.com/what-is-crispr-gene-editing-and-how-does-it-work-84591">What is CRISPR gene editing, and how does it work?</a>
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<p>The authors on the Nature report include some leaders in the development of CRISPR technologies, as well as bioethicists.</p>
<p>They propose a framework in which nations commit to not approve any clinical use of heritable gene editing unless some conditions are met on technical, societal, medical and ethical grounds. </p>
<p>In that process, they also argue that there should be an initial period during which no clinical use of germline editing is allowed at all. Research would still be allowed, provided embryos are used only in the very early stages in laboratory studies, and not transferred to a woman’s uterus to develop further. They suggest this period could last five years.</p>
<p>After this initial period, any participating country could allow a particular application of germline editing by following three steps: </p>
<ol>
<li>public notice of intent</li>
<li>transparent evaluation and justification of the application (considering not only the scientific and medical aspects, but also the related societal and ethical issues)</li>
<li>achievement of a broad consensus in the nation that this is an acceptable application.</li>
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Read more:
<a href="http://theconversation.com/researcher-claims-crispr-edited-twins-are-born-how-will-science-respond-107693">Researcher claims CRISPR-edited twins are born. How will science respond?</a>
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<h2>It’s about more than just science</h2>
<p>It is important that the evaluation considers not only the science of germline genetic modifications, but also the broader societal context. The authors mention the risk of discrimination, peer and marketing pressure, and unequal access to the technology if gene editing became available as a tool, for example in IVF clinics.</p>
<p>This moratorium would be limited to human germline editing only. This means modifying human sperm, eggs or embryos to make children whose DNA has been altered. Such changes pass through the generations, which is why germline editing is a particular area of concern. </p>
<p>The moratorium would not apply to changes in human cells not capable of reproduction (called somatic gene editing). <a href="https://www.nature.com/articles/d41587-018-00003-2">Current efforts to treat blindness, sickle cell disease or cancer using CRISPR</a> would not be affected by the moratorium. </p>
<h2>Implications in Australia</h2>
<p>In Australia, germline genetic modification is not allowed, and is illegal.</p>
<p>According to the <a href="https://www.legislation.gov.au/Details/C2017C00306">Prohibition of Human Cloning for Reproduction Act (2002)</a> researchers can face up to 15 years in jail for modifying “the genome of a human cell in such a way that the alteration is heritable by descendants of the human whose cell was altered”. Therefore the implications for Australia will be limited, and applying the initial five-year freeze on any clinical use of germline editing would be seamless. </p>
<p>If Australia wishes to allow any clinical application of germline editing at some point in the future, this act would need to be revised. </p>
<p>The framework proposed in the moratorium call provides a basis for how such a revision could then be discussed: public notice, transparent and comprehensive consideration of the application, and national discussion. </p>
<h2>Voluntary and pragmatic</h2>
<p>The proposed moratorium is voluntary. This is a pragmatic approach. It would be very difficult to get international agreement on a ban. </p>
<p>As the authors note, <a href="https://www.nature.com/articles/palcomms201719">discussions on a legally binding convention to outlaw human cloning are not making much progress</a>. </p>
<p>In the absence of a binding agreement, a voluntary pledge can start to move the main stakeholders towards a workable solution. Other issues such as climate change have shown the limitations of international agreements, but even getting a limited number of countries on board would be a positive first step.</p>
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<strong>
Read more:
<a href="http://theconversation.com/designer-babies-wont-be-common-anytime-soon-despite-recent-crispr-twins-108342">'Designer' babies won't be common anytime soon – despite recent CRISPR twins</a>
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<h2>Change requires commitment</h2>
<p>The authors also call on those who work in fields where CRISPR is used, including the leaders of research institutes as well as individual researchers, to publicly pledge to the principles of the framework they have outlined. </p>
<p>It will be interesting to see how some other stakeholders respond. For instance, will funding agencies and scientific publishers come on board? One objection to moratoriums is that they do not prevent “rogue” entities or individuals from operating outside their framework. </p>
<p>If it was clear that no study would be funded or published unless it adhered to the principles of advance notice, full transparency and national approval, it would remove some of the incentives that sometimes turn scientific research into a race.</p>
<p>Ultimately, in each country, society as a whole will have to decide whether germline editing is acceptable, and under which circumstances. A meaningful consensus will only be achieved if an informed discussion takes place. </p>
<p>To date, issues around gene editing have been <a href="http://www.nationalacademies.org/gene-editing/2nd_summit/">mostly discussed among experts</a>. More than ever, engagement and education that includes diverse members of our society around advanced biotechnologies is crucial.</p><img src="https://counter.theconversation.com/content/113463/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dimitri Perrin has received funding from the Australian Research Council (ARC), the Australian-French Association for Innovation and Research (AFRAN), and the Advance Queensland programme.</span></em></p><p class="fine-print"><em><span>Gaetan Burgio receives funding from the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC), the National Collaborative Research Infrastructure Strategy (NCRIS) via the Australian Phenomics Network (APN) and the Natural Science Foundation in China (NSFC). </span></em></p>Four months ago a researcher claimed he had used the tool CRISPR to edit the genomes of twin girls. Now prominent researchers and ethicists are calling for a temporary halt to this sort of work.Dimitri Perrin, Senior Lecturer, Queensland University of TechnologyGaetan Burgio, Geneticist and Group Leader, The John Curtin School of Medical Research, Australian National UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1123582019-02-26T11:40:32Z2019-02-26T11:40:32ZGene-edited food regulations: whether it's a plant or animal shouldn't matter, but it does now<figure><img src="https://images.theconversation.com/files/260754/original/file-20190225-26165-34bbkc.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Cows at the University of California, Davis beef research facility. Photo credit: </span> <span class="attribution"><span class="source">Alison Van Eenennaam/ University of California, Davis</span>, <a class="license" href="http://creativecommons.org/licenses/by-nc-sa/4.0/">CC BY-NC-SA</a></span></figcaption></figure><p>We eat mutations every day. All the vegetables, grains, fruits and meat humans consume as part of their diet are jam-packed with DNA speckled with mutations and beneficial variations. </p>
<p>In 2017, the <a href="https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.pdf">United States Food and Drug Administration proposed</a> to regulate a specific subset of these variations as drugs: in particular, those introduced into animal genomes using modern molecular techniques like gene editing. A drug is “an article (other than food) intended to affect the structure or any function of the body of animals” according to the Federal Food, Drug, and Cosmetic Act, which was first signed into law by President Franklin D. Roosevelt in 1938.</p>
<p>I am a <a href="https://animalscience.ucdavis.edu/people/faculty/alison-van-eenennaam">geneticist</a> who specializes in how genetics can be used to improve the efficiency of livestock production. While I agree that DNA variation undoubtedly affects “the structure and function of the body of animals,” it is unclear to me why intentional DNA alterations introduced via gene editing in food animals should uniquely be considered a drug. This seems inconsistent given that the United States Department of Agriculture has no plans to treat such alterations in gene-edited plants as drugs because genetic variations are part of conventionally bred varieties. Ultimately this ruling may hinder the use of gene editing to introduce useful attributes – like disease resistance – into U.S. livestock populations.</p>
<h2>Is DNA a drug?</h2>
<p>DNA – the double-stranded helix that encodes the recipe of life – is definitely a chemical. Everything is made of chemicals - even natural food. DNA, short for deoxyribonucleic acid, is made up of a unique arrangement of four nucleotides: adenine, cytosine, guanine and thymine. But is DNA a drug?</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/260757/original/file-20190225-26165-1jz3zju.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/260757/original/file-20190225-26165-1jz3zju.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=477&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/260757/original/file-20190225-26165-1jz3zju.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=477&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/260757/original/file-20190225-26165-1jz3zju.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=477&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/260757/original/file-20190225-26165-1jz3zju.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=599&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/260757/original/file-20190225-26165-1jz3zju.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=599&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/260757/original/file-20190225-26165-1jz3zju.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=599&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">The structure of double-stranded deoxyribonucleic acid (DNA) with pairs of nucleotides: cytosine-guanine and thymine–adenine.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/schematic-illustration-shows-structure-double-stranded-1112556215">Soleil Nordic/Shutterstock.com</a></span>
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</figure>
<p>DNA is present in each cell where it encodes the formation and functioning of all of the proteins that comprise the smooth functioning of our body and mind and also the deleterious mutations that can cause cancer or inherited conditions such as sickle cell anemia. </p>
<p>But when DNA is in our diet as a component of food, it is digested and broken into its constituent nucleotides, which are then absorbed and become the genetic building blocks of the eater. Eating a banana poses no risk of transforming the consumer into a banana, despite the fact that a banana is chock-full of cells each containing the entire banana genome. </p>
<h2>Conventional breeding and gene editing</h2>
<p>Selection for more productive and resilient plant and animal varieties has been an incredibly important component of reducing the environmental footprint of food production. Breeders select only the most suitable and fit parents to produce the next generation. Since 1960, global livestock productivity has <a href="https://doi.org/10.1098/rstb.2010.0134">increased 20 to 30 percent</a>, due in large part to genetic improvements resulting from selective breeding. </p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/260769/original/file-20190225-26162-1cohdy4.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/260769/original/file-20190225-26162-1cohdy4.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=893&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/260769/original/file-20190225-26162-1cohdy4.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=893&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/260769/original/file-20190225-26162-1cohdy4.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=893&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/260769/original/file-20190225-26162-1cohdy4.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=1122&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/260769/original/file-20190225-26162-1cohdy4.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=1122&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/260769/original/file-20190225-26162-1cohdy4.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=1122&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Gene editing enables geneticist to make precise changes to DNA.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/hand-scientist-replacing-dna-genetic-engineering-1012198108?src=bVms_r7HQ-wGM_mR5zxjOA-2-52">andriano.cz/Shutterstock.com</a></span>
</figcaption>
</figure>
<p>For instance, a glass of milk in the United States today has only <a href="https://doi.org/10.2527/jas.2009-1781">one-third the carbon footprint</a> of a glass of milk from 1944. Improved genetics are a key component of sustainability. </p>
<p>Although plants and animals produced in conventional breeding programs are routinely measured for production performance, susceptibility to disease, fertility and product quality, they are not normally evaluated at the DNA level prior to commercial release. Tremendous DNA sequence variation, or mutations, exists between perfectly healthy, unremarkable individuals of the same species. </p>
<p>To put this in perspective, one study of whole genome sequence data from over 2,700 bulls in the <a href="https://doi.org/10.1146/annurev-animal-020518-115024">1000 Bull Genomes Project</a> revealed over 86 million genetic variations between individual bulls of the same species. These included 2.5 million insertions or deletions of one or more nucleotides, and 84 million nucleotide variants, in which one nucleotide substituted for another. No two steaks from different animals are genetically alike, and every meal you have ever eaten contained a unique assembly of DNA sequences. </p>
<p>Gene editing, which uses tools like CRISPR/Cas9, provides an opportunity to make targeted DNA alterations. Some examples of edited livestock include pigs in which <a href="http://doi.org/10.1038/nbt.3434">a small deletion provides resistance</a> to the devastating porcine reproductive and respiratory syndrome virus. In dairy cows, some edits yield <a href="http://doi.org/10.1038/nbt.3560">animals that don’t grow horns</a>, sparing cows from the painful process of physical removal. I believe these edits benefit animal health and welfare, both improvements that tend to be <a href="https://www.ncbi.nlm.nih.gov/pubmed/23567982">more favorably viewed</a> by the public than those associated with production efficiency.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/260761/original/file-20190225-26159-dofiiu.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/260761/original/file-20190225-26159-dofiiu.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=375&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/260761/original/file-20190225-26159-dofiiu.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=375&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/260761/original/file-20190225-26159-dofiiu.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=375&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/260761/original/file-20190225-26159-dofiiu.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=471&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/260761/original/file-20190225-26159-dofiiu.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=471&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/260761/original/file-20190225-26159-dofiiu.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=471&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Animal biology graduate student Maci Mueller edits bovine embryos at the University of California, Davis.</span>
<span class="attribution"><span class="source">Alison Van Eenennaam/University of California, Davis.</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<h2>Human intention results in a drug</h2>
<p>Such applications are unlikely to reach the market if intentional DNA alterations are regulated as drugs. The mandatory approval process for animal drugs is understandably rigorous. It requires proof that the drug works, the absence of harmful residues in food animal products, and both animal and environmental safety. </p>
<p>What is unclear is how DNA alterations fit into this rubric. There is nothing fundamentally hazardous about genetic variation in food, and suggesting intentional alterations are equivalent to drugs will frighten consumers who might logically infer the presence of drugs in their food.</p>
<p>How can the absence of something, a snippet of DNA – as in the case of a deletion – be considered “a drug residue,” when an analogous deletion in the <a href="http://doi.org/10.1038/nature.2016.19754">genome of a mushroom</a> is not? </p>
<p>When I think of a drug I picture something like aspirin – a chemical with biological activity, often taken to prevent or treat a disease. As with most things in life, a small dose can be helpful, and a high dose can cause harm. </p>
<p>With this in mind, how should drug efficacy be evaluated in the case of genome-edited hornless cows – apart from the obvious fact that such animals don’t grow horns? The <a href="http://doi.org/10.1371/journal.pone.0063512">hornless variant</a> exists naturally in many beef breeds, including Angus. But, that same DNA sequence introduced through editing into dairy breeds, will be regulated as a drug.</p>
<p>Some South American countries including <a href="http://doi.org/10.1080/21645698.2015.1114698">Argentina have indicated that gene-edited</a> plants and food animals won’t be treated differently from a regulatory perspective. If no DNA sequences novel to that species are introduced using gene editing, then no added regulatory oversight will be triggered. Brazil has <a href="https://doi.org/10.1038/d41586-019-00600-4">ruled</a> it will not regulate hornless cows as GMOs.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/260763/original/file-20190225-26149-3r9y4e.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/260763/original/file-20190225-26149-3r9y4e.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/260763/original/file-20190225-26149-3r9y4e.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=440&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/260763/original/file-20190225-26149-3r9y4e.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=440&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/260763/original/file-20190225-26149-3r9y4e.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=440&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/260763/original/file-20190225-26149-3r9y4e.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=552&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/260763/original/file-20190225-26149-3r9y4e.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=552&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/260763/original/file-20190225-26149-3r9y4e.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=552&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A hornless cow (left) inherited this trait from her gene edited sire, whereas horns are starting to emerge on the control cow (right).</span>
<span class="attribution"><span class="source">Alison Van Eenennaam/University of California, Davis</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
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<h2>Moving gene editing to permissive countries</h2>
<p>However, in the United States gene-edited food animals with intentional genomic alterations that could otherwise have been developed through traditional breeding will be subject to a multigenerational, pre-market evaluation as new animal drugs. </p>
<p>This evaluation will be undertaken irrespective of whether there is any risk or novelty associated with the alteration. Edits that exactly mimic existing sequence variations will trigger evaluation. Surely <a href="https://doi.org/10.1089/crispr.2017.0023">novel product risk</a>, if any, should be the focus of regulatory oversight, and not what method a breeder used to introduce genetic variation. </p>
<p>As a result, U.S. animal geneticists are starting to <a href="https://doi.org/10.1038/d41586-019-00600-4">move their gene-editing research</a> to other countries. Innovative <a href="https://www.realagriculture.com/2018/05/gene-editing-allows-for-polled-dairy-genetics-without-the-production-drag/">startups are forming partnerships</a> with foreign companies in countries with product risk-based regulatory systems. </p>
<p>In the absence of sensible regulation of the breathtaking genetic variation that exists naturally in our food species - which is <a href="https://www.fda.gov/food/ingredientspackaginglabeling/gras/">generally regarded as safe</a> - innovation will emigrate. If intentional DNA alterations are shoehorned into a century-old regulatory framework, research exploring the introduction of sustainability traits like disease resistance, climate adaptability and animal welfare into U.S. livestock breeding programs will be thwarted, harming American agriculture and food production.</p><img src="https://counter.theconversation.com/content/112358/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Alison Van Eenennaam receives public research funding from competitive grants awarded by the USDA National Institute of Food and Agriculture (NIFA), and the Biotechnology Risk Assessment Grant (BRAG) program. </span></em></p>According to current regulations, animals that have been genetically edited, like pigs or cows, are considered drugs. What are the consequences of such rules on American livestock and agriculture?Alison Van Eenennaam, Researcher, Department of Animal Science, University of California, DavisLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1107782019-02-04T04:21:01Z2019-02-04T04:21:01ZNew study confirms what scientists already know: basic research is under-valued<figure><img src="https://images.theconversation.com/files/256801/original/file-20190201-103164-n4ph98.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Revolutionary technologies like CRISPR are founded on discoveries uncovered through basic research that attracts very little attention. </span> <span class="attribution"><a class="source" href="https://www.flickr.com/photos/unitedsoybean/9621083361/in/photolist-fEbyTB-fEbyBR-fEbzLp-fEt9bW-fEt9Vu-S6eSj-kV19UN-cr7gZ3-cfFYGC-fGitZ9-ax5db7-7mJzna-pZavEa-48fT3Z-9jX3Pw-cuGKb5-o174vG-cuGK9J-613SBd-5wBrCN-bizfM-au5kc-cfG5y3-4Gnj9G-W5sdpW-G8ihPT-bxGb7D-TsEuH-fFTc3Q-W7PqrB-X">United Soybean Board/flickr </a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>In our fast-paced modern world there is an expectation that scientific breakthroughs occur quickly and efficiently. </p>
<p>We are bombarded with headlines hyping new findings: <a href="https://www.mirror.co.uk/news/world-news/scientists-find-cure-cancer-available-13924602">Scientists “find cure for cancer which will be available within A YEAR”</a>.</p>
<p>Many scientists know how unrealistic such claims are. </p>
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<p>My <a href="https://doi.org/10.1016/j.molmed.2018.12.003">new study</a> provides data confirming that ground-breaking research takes time, and that the basic research underpinning it is typically overlooked or under-valued.</p>
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Read more:
<a href="http://theconversation.com/funding-basic-research-plays-the-long-game-for-future-payoffs-100435">Funding basic research plays the long game for future payoffs</a>
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<p>During my undergraduate degree I was fascinated to learn that cutting-edge molecular biology techniques – those used for manipulating proteins, DNA and other molecules – come from nature. In this paper I analysed the development of <a href="http://philsci-archive.pitt.edu/15413/">eight important molecular techniques</a>, and showed they all were developed from basic biological research. </p>
<p>My case studies include the relatively new molecular technology known as <a href="https://theconversation.com/funding-basic-research-plays-the-long-game-for-future-payoffs-100435">CRISPR-Cas</a> (now known as a precise DNA cutting tool, but which comes from biologists discovering how bacteria build immunity to viruses), and older technologies like <a href="https://theconversation.com/explainer-what-is-the-human-genome-project-7559">DNA sequencing</a> (developed thanks to biologists discovering how DNA copies itself). </p>
<h2>Scientific breakthroughs do not happen overnight</h2>
<p>I identified that the major breakthroughs in molecular technology take on average a quarter of a century from basic biological research to the practical payoff. This time frame is a lot longer than any election cycle or the funding period for a research project.</p>
<p>The long lead time before the payoff means it is difficult to calculate the exact benefit of funding basic biological research. But basic research has a major impact.</p>
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<em>
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Read more:
<a href="http://theconversation.com/funding-basic-research-plays-the-long-game-for-future-payoffs-100435">Funding basic research plays the long game for future payoffs</a>
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<p>A loose estimate suggests that the return on investment of funding basic research is <a href="https://doi.org/10.1126/science.342.6160.817">between 20-60% per year</a>! In Australia, every $1 invested into our National Health and Medical Research Council returns $3.20 in <a href="https://asmr.org.au/asmr-2018-fact-sheet/">health and economic benefits</a>. </p>
<h2>Scientific glory is not bestowed upon basic research</h2>
<p>I found the basic research that led to the development of new and important molecular technologies is not well recognised by the scientific community. </p>
<p>Basic research findings are not favoured by the science publication model. When you compare scientific articles describing basic research to applied research, the former is less likely to be published in high-profile journals or to be highly cited. </p>
<p>This is an important point, because scientific articles are key to <a href="https://theconversation.com/predicting-who-will-publish-or-perish-as-career-academics-18473">career progression in science</a>. Scientists who dedicate their careers to basic research make vital contributions to science but find it harder to obtain funding and have fewer career advancement opportunities. </p>
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<strong>
Read more:
<a href="http://theconversation.com/predicting-who-will-publish-or-perish-as-career-academics-18473">Predicting who will publish or perish as career academics</a>
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<p>Molecular technologies transform the world, and that is why the eight case studies have all eventually been linked with the awarding of <a href="https://www.nobelprize.org/prizes/">Nobel Prizes</a> (or are expected to be, in the case of CRISPR-Cas). </p>
<p>However, I found that the researchers who conduct basic research are less likely to be awarded the Nobel Prize or the relevant patents for the development of these molecular biology techniques.</p>
<p>We need to ensure the contributions of basic research scientists are recognised.</p>
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<p>
<em>
<strong>
Read more:
<a href="http://theconversation.com/science-can-be-beautiful-but-please-dont-call-it-basic-79188">Science can be beautiful, but please don't call it basic</a>
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</p>
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<h2>Basic research made the modern world feasible</h2>
<p>If basic biological research had never been pursued by scientists, then today’s world would be a very different and scarier place. </p>
<p>For instance, most of our current advances in human health would never have occurred. Consider the following examples:</p>
<ul>
<li>detection of pathogens causing infectious diseases (eg Zika virus) <a href="http://apps.who.int/iris/bitstream/handle/10665/204671/WHO_ZIKV_LAB_16.1_eng.pdf;jsessionid=DD73EFE09CB0AA233A5D41D8016A4026?sequence=1">using PCR</a> (a technique that copies DNA)</li>
<li>medical therapies using <a href="https://www.the-scientist.com/news-opinion/first-rnai-therapy-approved-by-fda-64633">RNA interference</a> (a technique that lowers accumulation of damaging proteins in a nerve disorder)</li>
<li>identification of genetic diseases (eg cystic fibrosis) using <a href="https://doi.org/10.1038/gim.2017.32">DNA sequencing</a></li>
<li>editing the genome (including cancer therapies) <a href="https://scienceblog.cancerresearchuk.org/2017/04/21/crispr-genome-editing-and-immunotherapy-the-early-adopter/">using CRISPR-Cas</a>.</li>
</ul>
<p>Molecular technologies arising from basic biological research play a critical role in diagnosis and treatment of diseases. </p>
<p>These molecular technologies are also powerful research tools that are critical for the progress of further biomedical research, such as <a href="https://doi.org/10.1038/s41586-019-0875-2">modelling complex human diseases</a> and <a href="https://doi.org/10.1038/s41586-018-0858-8">understanding the effect of diabetes on blood vessels</a>.</p>
<p>Further, these molecular technologies have enabled many other aspects of our modern world: they are crucial for <a href="https://doi.org/10.1038/543302a">agriculture</a>, have <a href="https://doi.org/10.1126/science.355.6326.680">led to entirely new industries and also created numerous jobs</a>.</p>
<p>Basic research has major impacts on society, is worthy of investment, but is chronically <a href="https://researchaustralia.org/budget-2018-19-budget-summary/">underfunded</a>. </p>
<h2>Funders need to be like angel investors</h2>
<p>It’s important that funding bodies have a realistic understanding of the time frame for basic research. Some appear to be <a href="https://www.theguardian.com/australia-news/2018/oct/31/academics-will-have-to-pass-national-interest-test-for-public-funding-coalition-says">investing in research only when it has a good prospect of being useful</a> – in the sense that it will provide quick returns. </p>
<p>Scientists are also increasingly pressured to obtain funding from non-government sources such as <a href="https://www.arc.gov.au/grants/linkage-program/linkage-projects">industry</a>. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="http://theconversation.com/with-federal-funding-for-science-on-the-decline-whats-the-role-of-a-profit-motive-in-research-93322">With federal funding for science on the decline, what's the role of a profit motive in research?</a>
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<p>We need a new investment approach from government funding agencies. The best strategy for high-risk ventures, such as basic research, is to provide stable funding to a wide variety of projects to diversify the risk. If we cast a wider net, we ensure we will always catch one of these “big fish”. </p>
<p>Funders can think of themselves as angel investors who are investing in a portfolio of start-up businesses (another type of venture that is high risk but also high reward).</p>
<p>The expectation of government funding agencies needs to be that most investments in basic research will not provide a return on investment. Data suggests that for start-up businesses, the <a href="https://www.forbes.com/sites/theyec/2017/08/10/the-angel-investors-dilemma/#7ddab9a54216">failure rate is as high as 60%</a>.</p>
<p>A few projects will return what was invested into them. But some research projects will be priceless scientific breakthroughs – <a href="https://doi.org/10.1126/science.342.6160.817">these are known to occur with some regularity</a>. Our modern world is built upon them. </p>
<p>If funding agencies are not consistently funding today’s basic research projects, then the revolutionary technologies of tomorrow will never be developed.</p><img src="https://counter.theconversation.com/content/110778/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Isobel Ronai does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>On average, important new lab techniques like CRISPR take 23 years to develop – but there is a public expectation that scientific breakthroughs occur quickly and efficiently.Isobel Ronai, Postdoctoral research fellow, University of SydneyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1083422018-12-11T19:04:53Z2018-12-11T19:04:53Z'Designer' babies won't be common anytime soon – despite recent CRISPR twins<figure><img src="https://images.theconversation.com/files/249584/original/file-20181210-76956-re0ghs.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Editing just one gene in an embryo could create many unanticipated side-effects once the baby is born. </span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/newborn-baby-hospital-638374354?src=h35UceDT_U42BqmZZnlmng-1-3">from www.shutterstock.com </a></span></figcaption></figure><p><em>This article is part of our occasional long read series <a href="https://theconversation.com/au/topics/zoom-out-51632">Zoom Out</a>, where authors explore key ideas in science and technology in the broader context of society and humanity.</em></p>
<hr>
<p>Despite reports that <a href="https://theconversation.com/researcher-claims-crispr-edited-twins-are-born-how-will-science-respond-107693">two genetically modified babies</a> have been born in China I don’t think you’ll be seeing designer babies soon. </p>
<p>This is not just because the laws in many countries, and scientific norms in others, prevent this, but for a much simpler reason: genome editing technology has, and will always have, limits. Limits that are related not to the technology itself but to the intrinsic complexity of the human genome. </p>
<p>In addition, the costs and risks of the procedures will outweigh the benefits for the foreseeable future.</p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="http://theconversation.com/what-is-crispr-gene-editing-and-how-does-it-work-84591">What is CRISPR gene editing, and how does it work?</a>
</strong>
</em>
</p>
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<p>Some people may doubt this. But remember, making <a href="https://en.wikipedia.org/wiki/Genetically_modified_mouse">genetically modified mice</a> became routine back in the 1980s and animals have been <a href="https://www.genome.gov/25020028/cloning-fact-sheet/">cloned</a> (genetic “copies” made) since the 1990s. And yet until the <a href="https://theconversation.com/researcher-claims-crispr-edited-twins-are-born-how-will-science-respond-107693">announcement of the CRISPR babies</a> – still yet to be confirmed by a peer-reviewed publication – there were no credible attempts to apply genetic technologies to viable human embryos.</p>
<p>There has been talk of designer babies for years but in my view they will remain (as they are now) very, very rare, for quite a while yet.</p>
<h2>Baby 007</h2>
<p>Let’s look at a hypothetical case study. Imagine you want to start a family, and would like your child to look like the latest James Bond. You ask a fertility doctor if she can conduct a kind of “genetic surgery” to change the genes of your embryo. </p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/249585/original/file-20181210-76974-1fdzw5m.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/249585/original/file-20181210-76974-1fdzw5m.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/249585/original/file-20181210-76974-1fdzw5m.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=352&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/249585/original/file-20181210-76974-1fdzw5m.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=352&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/249585/original/file-20181210-76974-1fdzw5m.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=352&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/249585/original/file-20181210-76974-1fdzw5m.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=443&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/249585/original/file-20181210-76974-1fdzw5m.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=443&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/249585/original/file-20181210-76974-1fdzw5m.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=443&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Same same, but different: six wax versions of James Bond.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/london-uk-december-2015-madame-waxwork-1128135506?src=WxUUfZP_d5mlW8UL1oqLxw-1-3">from www.shutterstock.com</a></span>
</figcaption>
</figure>
<p>In simple terms she can’t. You would have to change thousands of genes. Firstly, no one can identify which genes would lead to such an outcome. Secondly, and from a practical point of view, CRISPR only enables researchers to change a handful of genes at a time.</p>
<p>So you think again. Maybe you imagine your baby having the eyes of Jesse Williams, or the hair of Jay-Z? A genetic surgeon still can’t guarantee success. Even just the colour of eyes and hair are the result of complex genetic interactions. </p>
<p>Perhaps you’d rather parent a sporting superstar, like tennis player Karolina Pliskova (1.86m tall). One day it might be possible to “design” a daughter with this height by adjusting genes that control growth hormones. But again, multiple different – background – genes will have an impact, and you can’t be sure of getting the level right. </p>
<p>The risks here are significant. Ethics aside, it would be much simpler to inject hormones to promote growth rather than play with genes and risk your child growing to an unpredictable height (plus other unknown consequences).</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/249583/original/file-20181210-76977-fvgyb4.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/249583/original/file-20181210-76977-fvgyb4.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=451&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/249583/original/file-20181210-76977-fvgyb4.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=451&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/249583/original/file-20181210-76977-fvgyb4.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=451&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/249583/original/file-20181210-76977-fvgyb4.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=567&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/249583/original/file-20181210-76977-fvgyb4.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=567&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/249583/original/file-20181210-76977-fvgyb4.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=567&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Being tall like Karolina Pliskova offers a distinct advantage in many sports.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/paris-france-june-1-karolina-pliskova-1016537848?src=SFFV9kd6mdkITNmfengrpA-1-63">from www.shutterstock.com</a></span>
</figcaption>
</figure>
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<p>
<em>
<strong>
Read more:
<a href="http://theconversation.com/researcher-claims-crispr-edited-twins-are-born-how-will-science-respond-107693">Researcher claims CRISPR-edited twins are born. How will science respond?</a>
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<p>Such poor predictability is not due to the limits of genome editing technology – the technology has moved fast to this point, and will no doubt advance further in capability over coming years. Rather, it is due to the interplay between the thousands of genes within our genomes.</p>
<p>On top of that, environmental inputs (the “nurture” part of our development) and epigenetic effects (where subtle chemical modifications, often in response to environmental impacts, influence the expression of certain genes) create further unpredictability. </p>
<p>For these reasons, we simply can’t start ordering physical characteristics off some sort of cosmetic genetic surgeon’s menu – let alone attempt to alter mental traits, like temperament or intelligence.</p>
<p>There is also the problem of trade offs involved in any change. The CRISPR-edited babies reportedly born in China were <a href="https://theconversation.com/researcher-claims-crispr-edited-twins-are-born-how-will-science-respond-107693">intended to be resistant to HIV</a>. It is not clear whether they will be – but even if they are, current knowledge suggests that they would also be more susceptible to <a href="https://www.ncbi.nlm.nih.gov/pubmed/25918237">influenza</a> and <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2118086/">West Nile virus</a>. This is due to the many roles that the edited CCR5 gene plays in our immune system. </p>
<p>There are few “free lunches” in human evolution. And few parents would play a game of trial and error with their offspring once they understand the risks.</p>
<h2>Preventing genetic disease</h2>
<p>Superficial traits aside, even using CRISPR editing to combat serious genetic disease is unlikely to be common. </p>
<p>In many countries genetic counselling is already used to reduce the risk of passing on genetic diseases, like <a href="https://www.who.int/genomics/public/geneticdiseases/en/index2.html">Tay-Sachs</a> (in which the accumulation of fatty substances in nerve cells causes paralysis, dementia, blindness, psychoses, and even death). </p>
<p>Increasingly, in the future, if parents suffering from or carrying genetic mutations, choose to have biological children, they might consider <a href="https://www.ivf.com.au/fertility-treatment/ivf-treatment">in vitro fertilisation (IVF)</a> and only proceed with unaffected embryos for a pregnancy. In the case of an existing pregnancy, pre-natal diagnosis can give parents information they can use to help them decide whether or not to terminate, or perhaps correct the cells in the embryo as explained below. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/249593/original/file-20181210-76989-1n80vu4.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/249593/original/file-20181210-76989-1n80vu4.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=479&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/249593/original/file-20181210-76989-1n80vu4.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=479&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/249593/original/file-20181210-76989-1n80vu4.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=479&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/249593/original/file-20181210-76989-1n80vu4.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=602&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/249593/original/file-20181210-76989-1n80vu4.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=602&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/249593/original/file-20181210-76989-1n80vu4.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=602&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">During IVF, a single cell can be safely removed from an embryo for genetic testing.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/human-cells-egg-208569940?src=YIqI-A3t-060HqkKmZvwEA-1-0">from www.shutterstock.com'</a></span>
</figcaption>
</figure>
<p>It’s possible in the near future that some genetic diseases will be treated at the level of fixing the genes within certain cells in embryos, children or adults, rather than modifying whole embryos. Here, the relevant cells could be taken out of the body, the genes corrected and then the cells injected back in. Blood diseases in which vital oxygen-carrying haemoglobin is defective, such as sickle cell disease and thalassemia, will <a href="https://theconversation.com/the-slow-climb-from-innovation-to-cure-treating-anaemia-with-gene-editing-67131">likely be cured in this way</a>. </p>
<p>In the cases of <a href="https://www.fiercebiotech.com/research/scientists-use-crispr-to-treat-genetic-liver-diseases-neonatal-and-adult-mice">liver</a> and <a href="http://time.com/5382101/crispr-muscular-dystrophy-in-dogs/">muscle</a> diseases it may be possible to inject harmless viruses carrying the genome editing agents into these organs.</p>
<p>It’s only in exceptionally rare instances that parents might ask for their embryo to be changed. Sickle cell disease (which leads to anaemia), or cystic fibrosis (that affects the respiratory, digestive and reproductive systems) are examples. Each disease results from two affected copies of the relevant gene coming together: one copy from each parent. If both parents were affected by one of these disorders – which, given these conditions are so rare, is improbable but possible – their only option for having an unaffected biological child would be gene editing.</p>
<p>But one still wouldn’t jump into editing the genome of an embryo, because we have to weigh up not only the benefits but also the risks. The risks are important – because if an unintended genetic change is made, and an unanticipated consequence follows, it could affect not only that child but future generations as well. </p>
<p>At present scientists have generally agreed <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11282018b">not to consider modifying human embryos</a> until we know enough about the technology to evaluate the risks, and unless society is on board. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="http://theconversation.com/tension-as-scientist-at-centre-of-crispr-outrage-speaks-at-genome-editing-summit-107807">Tension as scientist at centre of CRISPR outrage speaks at genome editing summit</a>
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<h2>Society must decide</h2>
<p>But it seems this consensus was recently broken. There is concern that in terms of Jiankui He’s work with CRIPSR in human embryos <a href="https://www.theatlantic.com/science/archive/2018/12/15-worrying-things-about-crispr-babies-scandal/577234/">we cannot be</a> sure of either the efficacy of the editing or the consequences of any unintended changes made to the genomes. (Jiankui He has apparently <a href="https://www.abc.net.au/news/2018-12-07/chinese-scientist-who-edited-twins-genes-he-jiankui-missing/10588528">gone missing</a> since his recent appearance at a genome editing summit).</p>
<p>I don’t expect many other scientists to follow his path for now. </p>
<p>In the future there may be rare cases where parents who both carry genes for serious genetic diseases do seek to have an unaffected child via gene editing, and perhaps society would sanction this choice. Where we would draw the line for editing less serious but also well-known genetic variations remains to be determined. In the more distant future actual genetic enhancements may well be contemplated but I think the reactions to Jiankui He’s work make this less rather than more likely. </p>
<hr>
<p>
<em>
<strong>
Read more:
<a href="http://theconversation.com/is-your-genome-really-your-own-the-public-and-forensic-value-of-dna-95786">Is your genome really your own? The public and forensic value of DNA</a>
</strong>
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<p>For now, CRISPR genome editing remains a revolutionary technology that is transforming biological research and will have many medical and agricultural applications. It’s also clear that different advances associated with genome sequencing, genetic privacy, and discrimination, will present us with many regulatory and ethical challenges in coming years. </p>
<p>But I don’t expect to be debating these issues with designer babies who have grown to adulthood. For the most part, that will remain science fiction.</p><img src="https://counter.theconversation.com/content/108342/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Merlin Crossley receives funding from the National Health and Medical Research Council and the Australian Research Council. He is on the Trust of the Australian Museum, is the Chair of the Board of UNSW Press, Deputy Chair of the Australian Science Media Centre, and Editorial Board of The Conversation and of the journal Bioessays.</span></em></p>Genome editing technology has, and will always have, limits. Limits that are related not to the technology itself but to the intrinsic complexity of the human genome.Merlin Crossley, Deputy Vice-Chancellor Academic and Professor of Molecular Biology, UNSWLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1078072018-11-28T11:40:40Z2018-11-28T11:40:40ZTension as scientist at centre of CRISPR outrage speaks at genome editing summit<figure><img src="https://images.theconversation.com/files/247685/original/file-20181128-32180-1c4j5ay.png?ixlib=rb-1.1.0&amp;rect=1299%2C0%2C2598%2C1856&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Jiankui He claims he has used CRISPR to edit the genomes of twin girls. </span> <span class="attribution"><span class="source">Merlin Crossley</span>, <span class="license">Author provided</span></span></figcaption></figure><p>I am currently at the <a href="http://www.nationalacademies.org/gene-editing/2nd_summit/index.htm">Second International Summit on Human Genome Editing</a>, where controversial CRISPR scientist Jiankui He presented his research just a few hours ago. He also answered questions from gene experts Robin Lovell-Badge (Crick Institute) and Matt Porteus (Stanford), plus assembled audience members and the media. </p>
<p>It’s just two days since <a href="https://www.technologyreview.com/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/">reports first aired</a> that Jiankui He had <a href="https://theconversation.com/researcher-claims-crispr-edited-twins-are-born-how-will-science-respond-107693">used CRISPR to edit human embryos</a>, and that twin girls, Lulu and Nana, had been born. </p>
<hr>
<p>
<em>
<strong>
Baca juga:
<a href="http://theconversation.com/researcher-claims-crispr-edited-twins-are-born-how-will-science-respond-107693">Researcher claims CRISPR-edited twins are born. How will science respond?</a>
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</em>
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<p>The mood of the meeting is tense. Before these reports, there had been confidence among those in the field that the world was moving as one – cautiously inching forward with CRISPR gene editing technology. </p>
<p>But suddenly the forbidden fruit has been plucked, and some even worry that public confidence may falter.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/247672/original/file-20181128-32230-cy6sjt.JPG?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/247672/original/file-20181128-32230-cy6sjt.JPG?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=600&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/247672/original/file-20181128-32230-cy6sjt.JPG?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=600&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/247672/original/file-20181128-32230-cy6sjt.JPG?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=600&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/247672/original/file-20181128-32230-cy6sjt.JPG?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=754&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/247672/original/file-20181128-32230-cy6sjt.JPG?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=754&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/247672/original/file-20181128-32230-cy6sjt.JPG?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=754&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Jiankui He arrives to speak at the 2nd International Summit on Genome Editing, Hong Kong November 28, 2018.</span>
<span class="attribution"><span class="source">Merlin Crossley</span>, <span class="license">Author provided</span></span>
</figcaption>
</figure>
<p>Jiankui He focused on removing a gene called CCR5, critical for the HIV virus to enter cells. He aimed to mimic a natural mutation which confers resistance to HIV. This work is now on hold and an uncomfortable international discussion has begun. </p>
<p>The stories, and a <a href="https://www.youtube.com/watch?v=th0vnOmFltc&amp;feature=youtu.be">video published by Jiankui He</a> in which he explains the apparent work, have created <a href="https://theconversation.com/worlds-first-gene-edited-babies-premature-dangerous-and-irresponsible-107642">widespread condemnation</a> on <a href="https://theconversation.com/why-we-are-not-ready-for-genetically-designed-babies-107756">scientific and ethical grounds</a>.</p>
<p>If the claims are correct, and they are certainly plausible, this is the first time CRISPR has been used to create permanent changes in human genomes – changes that would be passed on to future generations. </p>
<p>Jiankui He himself is experienced in using CRISPR – he first carried out pilot experiments in mice, monkeys, and then non-viable human embryos. He also says he carried out a genomic analysis on the embryos before implantation, and that he had enrolled and worked with a further six couples in this trial before it was paused. One of the additional women may be in the very early stages of pregnancy. </p>
<hr>
<p>
<em>
<strong>
Baca juga:
<a href="http://theconversation.com/worlds-first-gene-edited-babies-premature-dangerous-and-irresponsible-107642">World's first gene-edited babies? Premature, dangerous and irresponsible</a>
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</em>
</p>
<hr>
<h2>International consensus</h2>
<p>China is a major scientific power. The capability of Chinese researchers is highly respected, but if the international consensus on being transparent and cautious about gene editing does not hold the future is difficult to predict. </p>
<p>Jiankui He’s host institution – the Southern University of Science and Technology – <a href="https://www.sustc.edu.cn/news_events_/5524">published a statement</a> saying he had been on leave at the time of the trial and that it was not conducted at their institution. </p>
<p>Currently other Chinese researchers in attendance at the conference are among the strongest critics of this work. Several have indicated that it breaks the rules governing genetic research in China. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/247675/original/file-20181128-32203-12knrb9.JPG?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/247675/original/file-20181128-32203-12knrb9.JPG?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=600&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/247675/original/file-20181128-32203-12knrb9.JPG?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=600&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/247675/original/file-20181128-32203-12knrb9.JPG?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=600&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/247675/original/file-20181128-32203-12knrb9.JPG?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=754&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/247675/original/file-20181128-32203-12knrb9.JPG?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=754&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/247675/original/file-20181128-32203-12knrb9.JPG?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=754&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Robin Lovell-Badge (Crick Institute), Jiankui He and Matt Porteus (Stanford) prepare to talk on stage.</span>
<span class="attribution"><span class="source">Merlin Crossley</span>, <span class="license">Author provided</span></span>
</figcaption>
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<p>Be that as it may, the results seem clear. Today’s presentation suggests this was a thoroughly planned and executed project, where Jiankui He carefully communicated his results, first by <a href="https://www.youtube.com/watch?v=th0vnOmFltc&amp;feature=youtu.be">video</a>, and then followed up with his conference talk to share his data. Details on the process, the specific mutations and analysis used to screen for potentially harmful “off-target” genomic changes were also presented today. </p>
<p>On the data shown, it does look like genome editing was achieved. Though the actual mutations did not end up mimicking naturally occurring mutations in CCR5, so we can’t tell – and indeed may never know - whether the twins are resistant to HIV. </p>
<p>He also indicated the work had been submitted for publication in a peer reviewed journal. </p>
<h2>Many questions</h2>
<p>Hosting panel members Robin Lovell-Badge and Matt Porteus asked questions of Jiankui He after he had finished presenting – the whole presentation and the Q&amp;A is available for viewing <a href="https://livestream.com/NASEM/events/8464254/videos/184103056">here</a>. </p>
<p>The Chair of the Summit, Nobel Laureate <a href="https://www.nobelprize.org/prizes/medicine/1975/baltimore/facts/">David Baltimore</a>, spoke from the floor after the panel session. He expressed concerns that the work did not comply with the commitments made at the first Gene Editing Summit held three years ago, whereby:</p>
<blockquote>
<p>it would be irresponsible to proceed with any clinical use of germ line editing unless and until the safety issues had been dealt with. </p>
</blockquote>
<p>He added:</p>
<blockquote>
<p>I don’t think it has been a transparent process. We only found out about it after it’s happened and after the children are born. I personally don’t think that it’s medically necessary. </p>
</blockquote>
<p>And further: </p>
<blockquote>
<p>I think there’s been a failure of self-regulation by the scientific community because of a lack of transparency.</p>
</blockquote>
<p>He emphasised these comments came entirely from himself. </p>
<p>A statement from the organisers of the summit will be released tomorrow, and I expect it will re-iterate the need for caution, openness in planning and full transparency. </p>
<p>And, despite the shock, that’s what I hope we’ll get – ultimately CRISPR technology is slow, expensive and is used at the level of individuals not populations. </p>
<p>There won’t be a tsunami but there will be plenty to discuss. And we will have time, just as we did when other expensive medical landmarks occurred - heart transplants, test tube babies, and somatic gene therapy. This is bigger, but I believe we can still get back to a consensus and find the right path.</p><img src="https://counter.theconversation.com/content/107807/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Merlin Crossley works for UNSW, receives funding from ARC and NHMRC, is on the Trust of the Australian Museum, Chair of the Board of UNSW Press, and Deputy Chair of the Australian Science Media Centre</span></em></p>The world seemed to be inching forward with CRISPR gene editing technology – but suddenly the forbidden fruit has been plucked, and some even worry that the CRISPR tree has been cut down.Merlin Crossley, Deputy Vice-Chancellor Academic and Professor of Molecular Biology, UNSWLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1077562018-11-27T23:19:43Z2018-11-27T23:19:43ZWhy we are not ready for genetically designed babies<figure><img src="https://images.theconversation.com/files/247608/original/file-20181127-76746-1ons9mi.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Any children born of genome editing are genetic mosaics with uncertain resistance to disease.</span> <span class="attribution"><span class="source">(Shutterstock)</span></span></figcaption></figure><p>The media is buzzing with the <a href="https://www.technologyreview.com/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/">surprise news</a> that a <a href="https://www.sciencemag.org/news/2018/11/crispr-bombshell-chinese-researcher-claims-have-created-gene-edited-twins">Chinese researcher, Jainkui He</a>, has <a href="https://www.apnews.com/4997bb7aa36c45449b488e19ac83e86d">created the world’s first genome-edited twins</a>. He did this, ostensibly, to provide resistance to HIV, the virus that causes AIDS.</p>
<p>Prof. He, reportedly working with former Rice University supervisor Michael Deem, capitalized on work in 2012 by Jennifer Doudna and Emmanuel Charpentier, who introduced a new and easier way of altering the DNA of human and non-human organisms using <a href="https://theconversation.com/beyond-just-promise-crispr-is-delivering-in-the-lab-today-77596">CRISPR-Cas9 technology</a>. He also built upon the work of molecluar biologist <a href="https://www.broadinstitute.org/bios/feng-zhang">Feng Zhang</a>, who optimized this genome editing system for use in human cells.</p>
<p>He’s claim moves human germline genome editing from the lab to the delivery room — something other scientists might have been thinking about despite <a href="https://impactethics.ca/2018/11/26/first-crispr-babies-where-are-our-ethics/">ethical concerns</a>. </p>
<figure>
<iframe width="440" height="260" src="https://www.youtube.com/embed/th0vnOmFltc?wmode=transparent&amp;start=0" frameborder="0" allowfullscreen></iframe>
<figcaption><span class="caption">Jainkui He explains why his lab edited the genome of twin baby girls, Nana and Lulu, when they were embryos.</span></figcaption>
</figure>
<p>The scientific community has expressed <a href="https://www.nature.com/articles/d41586-018-07545-0">widespread condemnation</a> of He’s decision to initiate a pregnancy using genetically modified embryos — as “dangerous, "irresponsible” and “crazy.” What if mistakes are made? How can we be sure this powerful technology will benefit humankind? Are we ready for the consequences of genetically engineering our own evolution?</p>
<p>We argue that we cannot allow individual scientists to decide the fate of the human genome. Heritable human genome editing poses a significant existential threat because changes may persist throughout the human population for generations, with unknown risks.</p>
<p>We must <a href="https://www.ctvnews.ca/health/you-can-t-pretend-to-be-god-experts-condemn-claimed-gene-editing-of-babies-1.4192563">commit to inclusive global dialogue</a> — involving experts and the public — to <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12032015a">develop broad societal consensus on what to do with genetic technologies</a>.</p>
<h2>Possible mutations or forced sterilization</h2>
<p>He announced to the world that he edited the genome of human embryos for seven couples using CRISPR-Cas9 technology. According to He, two of these embryos resulted in a pregnancy, and twin girls (Lulu and Nana, which are pseudonyms) were born. </p>
<p>The goal of the editing was to confer resistance to HIV by modifying the CCR5 gene (the protein doorway by which HIV enters human cells). He claims that these edits have been verified in both twins and <a href="https://www.statnews.com/2018/11/26/claim-of-crispred-baby-girls-stuns-genome-editing-summit/">this data has been looked over and called “probably accurate</a>” by George Church, a world-renowned Harvard geneticist.</p>
<p>Evidence suggests, however, the procedure was unnecessary, is unlikely to provide benefit and could even cause harm. Although the father of Lulu and Nana was HIV positive, it is unlikely that he would have passed this disease to his children using standard IVF procedures. </p>
<p>The children born of genome editing are genetic mosaics with uncertain resistance to HIV and perhaps decreased resistance to viral diseases like influenza and West Nile. This is because the CCR5 gene that He disabled plays an important role in resistance to these diseases. </p>
<p>As well, there is the possibility of unintended mutations caused by the CRISPR procedure. These health risks cannot be overstated, as the repercussions for these twin girls, in terms of their susceptibility to infectious diseases or cancer will likely be a cause for concern throughout their lives. </p>
<p>Another uncertain consequence for the twins concerns their reproductive health and freedom. As they approach reproductive age will they face the possibility of “forced” sterilization to prevent their edited genes being passed on to future generations?</p>
<h2>Multiple investigations</h2>
<p>The Southern University of Science and Technology in Shenzhen, China, where He is employed (currently on leave from February 2018 to January 2021), has distanced itself from the researcher and will form an independent international committee to <a href="http://sustc.edu.cn/en/info_focus/2871">investigate the widely publicized, controversial research</a>. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/247599/original/file-20181127-76737-nyfwu8.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/247599/original/file-20181127-76737-nyfwu8.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=401&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/247599/original/file-20181127-76737-nyfwu8.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=401&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/247599/original/file-20181127-76737-nyfwu8.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=401&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/247599/original/file-20181127-76737-nyfwu8.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=504&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/247599/original/file-20181127-76737-nyfwu8.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=504&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/247599/original/file-20181127-76737-nyfwu8.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=504&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Feng Zhang, center, an institute member of Harvard and MIT’s Broad Institute, reacts to reporters on the issue of world’s first genetically edited babies after the Human Genome Editing Conference in Hong Kong on Nov. 27, 2018.</span>
<span class="attribution"><span class="source">(AP Photo/Vincent Yu)</span></span>
</figcaption>
</figure>
<p>Rice University, where Michael Deem is employed, has also said <a href="https://www.statnews.com/2018/11/26/rice-university-opens-investigation-into-researcher-who-worked-on-crisprd-baby-project/">they will investigate</a>. </p>
<p>The Shenzhen HarMoniCare Women’s and Children’s Hospital launched an inquiry into the validity of the ethics documents provided by He documenting research ethics approval. </p>
<p>Importantly, the ethics approval was only uploaded to the Chinese Clinical Trial Database on Nov. 8 as a retrospective registration — likely around the time that the twins were purportedly born.</p>
<h2>Designer babies by powerful elites</h2>
<p>With the Genetic Genie out of the bottle, we have to ask whether we need any more time to reflect on the ethics?</p>
<p>A just and fair society is one with less disparity and more justice. A predictable consequence of allowing (nay, encouraging) individuals to genetically modify their children will be greater disparity and greater injustice — and not only because of limited access to genome editing technology. </p>
<p>Of significant concern is the inevitable increase in discrimination, stigmatization and marginalization as powerful scientific and corporate elites decide which traits are desirable and which traits are not. </p>
<p>Although He disavows any interest in so-called “designer babies” whose parents have chosen their children’s eye-colour, hair-colour, IQ and so on, we are forced to contemplate such a “eugenic” dystopian future should we continue down this path.</p>
<p>The human genome belongs to all of us. As such, we need to commit to the hard work of making good on the 2015 admonition by the Organizing Committee for the International Summit on Human Gene Editing to work towards <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12032015a">“broad societal consensus”</a> on how we should proceed with, or not proceed with, editing it.</p>
<p>In this regard it is heartwarming to have <a href="https://www.technologyreview.com/s/612465/crispr-inventor-feng-zhang-calls-for-moratorium-on-baby-making/">Feng Zhang</a> call for a moratorium on implantation of edited embryos and remind his scientific colleagues that “in 2015, the international research community said it would be irresponsible to proceed with any germline editing without ‘broad societal consensus about the appropriateness of the proposed application.’”</p><img src="https://counter.theconversation.com/content/107756/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Françoise Baylis has received funding from the Canadian Institute of Health Research and the Canada Research Chairs Program.</span></em></p><p class="fine-print"><em><span>Graham Dellaire receives funding from the Canadian Institutes of Health Research (CIHR).</span></em></p><p class="fine-print"><em><span>Landon J Getz receives funding from the Natural Sciences and Engineering Research Council of Canada. </span></em></p>Chinese researcher, Jainkui He claims to have created the world's first genome-edited twins. Such action would pose unknown risks to the lives of these children and to humanity as a whole.Françoise Baylis, Professor and Canada Research Chair in Bioethics and Philosophy, Dalhousie UniversityGraham Dellaire, Director of Research and Professor of Pathology, Dalhousie UniversityLandon J Getz, Ph.D. Candidate in Microbiology and Immunology, Dalhousie UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1076842018-11-27T15:13:11Z2018-11-27T15:13:11ZRogue science strikes again: The case of the first gene-edited babies<figure><img src="https://images.theconversation.com/files/247537/original/file-20181127-76764-sd4z6m.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Chinese scientists led by He Jiankui claimed they used CRISPR to modify human embryos that eventually were born as twin girls.</span> <span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Genetic-Frontiers-Gene-Edited-Babies/357555b59c0a41fb93a35eb0a938a38d/4/0">AP Photo/Mark Schiefelbein</a></span></figcaption></figure><p>The idea of scientists tinkering with the genes of babies was once the provenance of science fiction, but now it’s apparently entered the realm of reality: On Nov. 26, Chinese scientist He Jiankui reported the historic live births of <a href="https://www.apnews.com/4997bb7aa36c45449b488e19ac83e86d">twin girls whose genes he had edited</a>. The goal <a href="https://theconversation.com/the-road-to-enhancement-via-human-gene-editing-is-paved-with-good-intentions-107677">may have been noble</a>: to use CRISPR to alter their genes to include a variant protective against transmission of HIV. But the announcement – yet to be verified – has quickly become mired in a deluge of scientific and ethical <a href="https://theconversation.com/worlds-first-gene-edited-babies-premature-dangerous-and-irresponsible-107642">criticism</a> of He as a reckless researcher who overstepped well-established boundaries.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/247539/original/file-20181127-76764-1679rlk.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/247539/original/file-20181127-76764-1679rlk.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/247539/original/file-20181127-76764-1679rlk.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/247539/original/file-20181127-76764-1679rlk.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/247539/original/file-20181127-76764-1679rlk.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/247539/original/file-20181127-76764-1679rlk.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/247539/original/file-20181127-76764-1679rlk.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/247539/original/file-20181127-76764-1679rlk.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">He Jiankui has a lot to explain going forward.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Genetic-Frontiers-Gene-Edited-Babies/c5f8eb88e0e64fc3aed2b2388e0195ff/1/0">AP Photo/Mark Schiefelbein</a></span>
</figcaption>
</figure>
<h2>Professional outcry</h2>
<p>The reaction from the professional community of scientists and ethicists was swift and essentially universal in its condemnation, including by <a href="https://qz.com/1474530/chinese-scientists-condemn-crispr-baby-experiment-as-crazy/">over 100</a> of He’s colleagues in China.</p>
<p>A <a href="https://theconversation.com/worlds-first-gene-edited-babies-premature-dangerous-and-irresponsible-107642">central objection</a> is that the study was simply too risky. Researchers have stressed that the risk of off-target effects (unintentionally changing other genes) and mosaicism (only altering the target gene in some of the child’s cells rather than all of them) could lead to <a href="https://www.newscientist.com/article/2174149-crispr-gene-editing-is-not-quite-as-precise-and-as-safe-as-thought/">unexpected and harmful health effects</a> such as cancer later in life. There is general agreement that <a href="https://theconversation.com/heres-what-we-know-about-crispr-safety-and-reports-of-genome-vandalism-100231">at present these risks</a> outweigh any potential benefits, and more basic research is needed before proceeding.</p>
<p>Interestingly, some of the strongest ethical objections to the experiment came from ethicists who have in other venues defended gene editing. <a href="https://scholar.google.com/citations?user=PxdgzQUAAAAJ&amp;hl=en&amp;oi=ao">Julian Savulescu</a>, for example, has <a href="https://www.sciencenews.org/blog/science-public/ethics-gene-editing-babies-crispr">gone so far as to argue</a> that, if it were safe and not too costly, we would even have an obligation to edit our children’s genes. Yet <a href="http://blog.practicalethics.ox.ac.uk/2018/11/press-statement-monstrous-gene-editing-experiment/">he called</a> the reported experiment “monstrous,” in light of the serious risks and lack of necessity. The twins were never in danger of inheriting a deadly genetic disorder, and there are far less risky ways to prevent HIV transmission.</p>
<h2>Public perception</h2>
<p>This backlash may have caught He by surprise. According to one report, He commissioned a <a href="https://www.technologyreview.com/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/">large-scale public opinion survey in China</a> a few months prior to the announcement. The survey found that over <a href="http://scd.sysu.edu.cn/sites/scd.prod.dpweb3.sysu.edu.cn/files/2018-11/ChinesePublicAttitudesOnGeneEditing.pdf">70 percent of the Chinese public was supportive</a> of using gene editing for HIV prevention. This is <a href="http://www.pewinternet.org/2018/07/26/public-views-of-gene-editing-for-babies-depend-on-how-it-would-be-used/">roughly in line</a> with a recent Pew poll in the United States that found 60 percent of Americans support using gene editing on babies to reduce lifetime risk of contracting certain diseases.</p>
<p>But polling tells only part of the story. The same Chinese poll also found very low levels of public understanding of gene editing and did not mention the details of He’s study. Abstract polling questions ignore the risks and state of the science, which were crucial to most objections to He’s experiment. It also obscures the involvement of embryos in gene editing. In the American Pew poll, despite overall support for gene editing, 65 percent opposed embryonic testing – a necessary step in the process of gene editing to address disease.</p>
<p>Moreover, polling is a crude and simplistic way to engage in public debate and deliberation over the controversial issue of gene editing. Various bodies, such as the <a href="https://www.nap.edu/read/24623/chapter/1">National Academies of Sciences, Medicine and Engineering</a> in the U.S. and the <a href="http://nuffieldbioethics.org/wp-content/uploads/Genome-editing-and-human-reproduction-short-guide-website.pdf">Nuffield Council on Bioethics</a> in the U.K., have emphasized that, for gene editing to proceed to human trials, a robust public discussion is first needed to establish its legitimacy.</p>
<p>Yet He decided to proceed in the least transparent way possible, hiding his study from public view, colleagues and his institution, and even going so far as to <a href="http://www.sustc-genome.org.cn/source/pdf/Informed-consent-women-English.pdf">ban participants</a> from sharing with anyone their participation in the trial, on pain of financial penalty.</p>
<p>He’s recklessness, then, was not limited to risk but also failing to earn public trust and buy-in before proceeding.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/247541/original/file-20181127-76746-1xpfw30.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/247541/original/file-20181127-76746-1xpfw30.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/247541/original/file-20181127-76746-1xpfw30.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/247541/original/file-20181127-76746-1xpfw30.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/247541/original/file-20181127-76746-1xpfw30.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/247541/original/file-20181127-76746-1xpfw30.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/247541/original/file-20181127-76746-1xpfw30.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/247541/original/file-20181127-76746-1xpfw30.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">IVF can be prohibitively expensive, even without editing the embryos’ genes.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Genetic-Frontiers-Gene-Edited-Babies/be12da8f5c424f18b43be98f34b4545f/3/0">AP Photo/Mark Schiefelbein</a></span>
</figcaption>
</figure>
<h2>Consent and inducement</h2>
<p>A further failing of He’s experiment was the consent process. The study recruited couples with an HIV-positive husband and HIV-negative wife. Ostensibly, the couples had a particular interest in ensuring their children never contracted HIV, in light of the intended father’s experience. But looking a little closer reveals other, more problematic motivations.</p>
<p>For such couples, it is possible to safely conceive an HIV-negative child using <a href="https://academic.oup.com/humrep/article/22/3/772/2939095">robust IVF procedures</a>. Such therapy is expensive, prohibitively so for many couples. But He’s study offered a particularly enticing carrot – free IVF treatment and supportive care, along with a daily allowance and insurance coverage during the treatment and pregnancy. According to the <a href="http://www.sustc-genome.org.cn/source/pdf/Informed-consent-women-English.pdf">consent form</a>, the total value of treatments and payments was approximately US$40,000 – over four times the <a href="https://www.statista.com/statistics/278349/average-annual-salary-of-an-employee-in-china/">average annual wage</a> in urban China.</p>
<p>This raises a serious concern of <a href="https://www.dovepress.com/bioethical-issues-in-providing-financial-incentives-to-research-partic-peer-reviewed-fulltext-article-MB">undue inducement</a>: paying research participants such a large sum that it distorts their assessment of the risks and benefits. In this gene editing context, where the risks are incredibly uncertain and there is substantially limited general understanding of genetics and gene editing, society should be especially concerned about the distorting effect of such a large reward on the participants’ provision of free and informed consent.</p>
<h2>Aftermath</h2>
<p>In a <a href="https://www.youtube.com/watch?v=th0vnOmFltc&amp;t=140s">video</a> announcing the birth of the twins, He announced he was willing to take on all personal responsibility for the conduct and outcomes of the experiment. And indeed, the consequences of this unethical experiment are already piling up. His own university has disavowed him, having previously suspended him, while <a href="https://www.technologyreview.com/s/612466/the-chinese-scientist-who-claims-he-made-crispr-babies-has-been-suspended-without-pay/">multiple investigations</a> are being launched into He, his <a href="https://www.statnews.com/2018/11/26/rice-university-opens-investigation-into-researcher-who-worked-on-crisprd-baby-project/">American collaborator</a> and the hospital ethics committee that approved the experiment. </p>
<p>The outcome of those investigations remains to be seen, but it is part of a disturbing pattern in reproduction: rogue scientists bucking international norms to engage in ethically and scientifically dubious reproductive research. Indeed, just within the last two years another set of <a href="https://www.newscientist.com/article/2107219-exclusive-worlds-first-baby-born-with-new-3-parent-technique/">renegade</a> <a href="https://www.npr.org/sections/health-shots/2018/06/06/615909572/inside-the-ukrainian-clinic-making-3-parent-babies-for-women-who-are-infertile">scientists</a> flaunted established norms to bring about the first “three-parent IVF” babies; there was tremendous outcry, but the procedure now seems to be continuing in the relatively lax regulatory environment of Ukraine. </p>
<p>Hard work is now needed by scientists, ethicists, policymakers and the public at large to figure out how to reverse this trend and return reproductive medicine to a path of responsible research and innovation.</p><img src="https://counter.theconversation.com/content/107684/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>G. Owen Schaefer does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>The announcement of the birth of babies with edited genes has been met by a deluge of scientific and ethical criticism. Public discussion focuses on risks and benefits – was breaking this taboo worth it?G. Owen Schaefer, Research Assistant Professor in Biomedical Ethics, National University of SingaporeLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1076772018-11-27T12:40:11Z2018-11-27T12:40:11ZThe road to enhancement, via human gene editing, is paved with good intentions<figure><img src="https://images.theconversation.com/files/247373/original/file-20181126-140525-1pu35zm.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">A Chinese scientist claims he edited the DNA of twin girls during an in vitro fertilization procedure. </span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/vitro-fertilisation-ivf-cell-under-microscope-764231488?src=ENuyRzFDhQbVzA4lEBm-Yg-1-0">CI Photos / Shutterstock.com</a></span></figcaption></figure><p>It <a href="https://apnews.com/4997bb7aa36c45449b488e19ac83e86d">appears</a> that researchers in China have facilitated the birth of the first “designer baby” – actually babies, twin girls who are supposedly genetically resistant to HIV. The scientist who created the embryos, as well as some American scientists like Harvard’s George Church, have praised the beneficent intent to producing a child who is resistant to disease. Who could argue with such good intentions? </p>
<p>But, once you can do this with one gene, you could someday do it with any gene – like those linked with <a href="https://doi.org/10.1038/mp.2016.45">educational attainment</a>. Those who praise the Chinese research have given no mechanism, or rules and regulations, that would allow human gene editing for only beneficent purposes. As the old proverb says, “The road to hell is paved with good intentions.”</p>
<p>For over 20 years I have focused my research on debates about <a href="https://www.press.uchicago.edu/ucp/books/book/chicago/P/bo3621106.html">human gene editing</a> and <a href="https://global.oup.com/academic/product/what-is-a-human-9780190608071?q=evans%2C%20john%20hyde&amp;lang=en&amp;cc=us">other biotechnologies</a>. I have watched these debates unfold, but I am shocked by the recent speed of developments.</p>
<p>The Chinese scientist, He Jiankui, claimed to have altered embryos for seven couples during fertility treatment in China. His goal was to disable a gene that encodes a gateway protein that allows the HIV virus to enter a cell. A woman nurtured two of those embryos and this month gave birth to non-identical twin girls who would, according to He, be resistant to HIV. </p>
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<a href="https://images.theconversation.com/files/247399/original/file-20181126-140525-15knyis.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/247399/original/file-20181126-140525-15knyis.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/247399/original/file-20181126-140525-15knyis.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/247399/original/file-20181126-140525-15knyis.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/247399/original/file-20181126-140525-15knyis.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=400&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/247399/original/file-20181126-140525-15knyis.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/247399/original/file-20181126-140525-15knyis.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/247399/original/file-20181126-140525-15knyis.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=503&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Chinese scientist He Jiankui claims he helped make the world’s first genetically edited babies. He revealed the news on Monday, Nov. 26, in Hong Kong to one of the organizers of an international conference on gene editing.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Genetic-Frontiers-Gene-Edited-Babies/c5f8eb88e0e64fc3aed2b2388e0195ff/4/0">AP Photo/Mark Schiefelbein</a></span>
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<p>Given the secrecy involved, it is difficult to verify He’s claim. The research wasn’t published in a peer-reviewed journal, the parents of the twins refused to speak with the media, and no one has tested the DNA of the girls to verify what He says is true. But what is more important for now is that there are scientists trying to create these enhanced humans who could pass on this trait to their offspring.</p>
<h2>Mainline and reform eugenics</h2>
<p>Creating an “improved” human species has long been the dream of eugenicists. The mainline, old school version of eugenics assumed that superior traits were found in particular races, ethnicities, and particularly in the United Kingdom, social classes. This logic culminated in the Holocaust where the Nazis concluded that some ethnic groups are genetically superior to others, and that the “inferior” ones should be exterminated and completely erased. </p>
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<a href="https://images.theconversation.com/files/247409/original/file-20181126-140513-1m0g57a.jpeg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/247409/original/file-20181126-140513-1m0g57a.jpeg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/247409/original/file-20181126-140513-1m0g57a.jpeg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=807&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/247409/original/file-20181126-140513-1m0g57a.jpeg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=807&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/247409/original/file-20181126-140513-1m0g57a.jpeg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=807&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/247409/original/file-20181126-140513-1m0g57a.jpeg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=1015&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/247409/original/file-20181126-140513-1m0g57a.jpeg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=1015&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/247409/original/file-20181126-140513-1m0g57a.jpeg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=1015&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">This is a magazine published by the Office of Racial Policy of the Nazi Party while they were in power. The poster says: 60,000 Reichsmark is what this person suffering from hereditary illness costs the community in his lifetime. Fellow citizen, that is your money too.</span>
<span class="attribution"><a class="source" href="https://commons.wikimedia.org/wiki/File:Neues_Volk_eugenics_poster,_c._1937_(brightened).jpeg">Unknown author / Wikimedia Commons</a></span>
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<p>The revelation of the Holocaust destroyed mainline eugenics, but a <a href="http://www.hup.harvard.edu/catalog.php?isbn=9780674445574">“reform” eugenics</a> arose in its wake in the 1950s. This brand of eugenics assumed that “superior traits” could be found among all ethnic groups. All that needed to happen was to get these superior people to produce more children and discourage those with inferior traits from reproducing. This turned out to be difficult.</p>
<p>But in the early 1950s, Francis Crick and James Watson <a href="https://doi.org/10.1038/171737a0">discovered the chemical structure of DNA</a>, which suggested that the genes of humans could be improved through chemical modification of their reproductive cells. A typical response was from prominent biologist <a href="https://news.ucsc.edu/2017/04/robert-sinsheimer-in-memoriam.html">Robert Sinsheimer</a> <a href="https://www.press.uchicago.edu/ucp/books/book/chicago/P/bo3621106.html">who wrote in 1969</a> that the new genetic technologies of the time allowed for “a new eugenics.” According to Sinsheimer, the old eugenics required selecting fit individuals to breed and culling the unfit. “The new eugenics would permit in principle the conversion of all of the unfit to the highest genetic level … for we should have the potential to create new genes and new qualities yet undreamed.”</p>
<h2>The slippery slope of the gene editing debate</h2>
<p>The modern ethical debate about human gene editing can be traced back to this era. The debate was implicitly set up like a slippery slope. </p>
<p>At the top of the slope was an act of gene editing deemed indisputably virtuous – a step most people were willing to take – such as repairing sickle cell anemia. However, the slope was slippery. It is very difficult to say that changing other traits that are not deadly, like deafness, are not equally acceptable. Once you figure out how to change one gene, you can change any gene, regardless of its function. If we fix sickle cell, why not deafness, or late onset heart disease, or a lack of “normal” intelligence, or as we approach the bottom, a lack of superior intelligence?</p>
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<a href="https://images.theconversation.com/files/247407/original/file-20181126-140513-130f9qm.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/247407/original/file-20181126-140513-130f9qm.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/247407/original/file-20181126-140513-130f9qm.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=795&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/247407/original/file-20181126-140513-130f9qm.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=795&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/247407/original/file-20181126-140513-130f9qm.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=795&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/247407/original/file-20181126-140513-130f9qm.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=998&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/247407/original/file-20181126-140513-130f9qm.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=998&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/247407/original/file-20181126-140513-130f9qm.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=998&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Aldous Huxley wrote about a world in which everyone was genetically engineered and all opportunity was determined by your genetic code.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Associated-Press-International-News-United-King-/c36a840762e5da11af9f0014c2589dfb/3/0">AP Photo/Eraldo Peres</a></span>
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<p>At the bottom of the slope was the dystopian world where nobody wants to end up. This is typically depicted as a society based on total genetic control of offspring where people’s lives and opportunities are determined by their genetic pedigree. Today the bottom of the slope is represented by the late 1990s movie “<a href="https://en.wikipedia.org/wiki/Gattaca">Gattaca</a>.” </p>
<h2>Stepping onto the slope</h2>
<p>In the 1970s, essentially all of the participants in the debate stepped onto the slope and approved of somatic gene therapy – a strategy for healing genetic diseases in the bodies of living people where genetic changes would not be passed to any offspring. Participants in the ethical debate about gene editing stepped onto this slope because they were confident that they had blocked any possible slide by creating a strong norm against the modification of DNA that passed to the next generation: the germline wall. (The germline means influencing not only the person modified, but their descendants.) </p>
<p>Somatic changes could be debated, but researchers would not move beyond the wall to change people’s inheritance – to change the human species as the eugenicists had long desired. Another barrier to the road to hell that turned out to be permeable was the wall between blocking disease and enhancing an individual. Scientists could try to use gene editing to avoid genetic diseases, like sickle cell disease, but not to create “improved” humans.</p>
<p>The recent actions of the Chinese scientist leap over both the germline and the enhancement walls. It is the first known act of human germline gene editing. These twin girls may pass their newfound resistance to HIV to their own children. It is also not meant to avoid a genetic disease like sickle cell anemia, but to create an enhanced human, albeit an enhancement made in the name of fighting infectious disease.</p>
<h2>Calling for a new wall</h2>
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<iframe width="440" height="260" src="https://www.youtube.com/embed/qviOJRO2g0c?wmode=transparent&amp;start=0" frameborder="0" allowfullscreen></iframe>
<figcaption><span class="caption">A Chinese researcher claims that he helped create the world’s first genetically edited babies.</span></figcaption>
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<p>Unlike in earlier years of the human gene editing debate, we are given no argument for where these applications would stop. Those advocating the Chinese scientist’s use of gene editing do not point to a wall further down the slope that can be used to reassure ourselves that by allowing this presumably beneficent application we will not eventually end up at the bottom. Many scientists seem to think that a wall can be constructed with “disease” applications in the acceptable part of the slope and “enhancement” in the unacceptable part below. </p>
<p>However, how one defines “disease” is notoriously fluid, with pharmaceutical companies frequently creating new diseases to be treated in a process sociologists call <a href="https://books.google.com/books?hl=en&amp;lr=&amp;id=hYpZjDD67dkC&amp;oi=fnd&amp;pg=PR13&amp;dq=medicalization&amp;ots=GKrE5_HLc4&amp;sig=u-a7FNTRQn3Slg53MSS_Rs_vmBw#v=onepage&amp;q=medicalization&amp;f=false">medicalization.</a> Moreover, is deafness a disease? Many deaf people do not think so. We also cannot simply rely upon the medical profession to define disease, as some practitioners are engaged in activities that are more aptly described as enhancement (think plastic surgery). A <a href="https://doi.org/10.17226/24623">recent report</a> by the National Academy of Sciences concluded that the distinction between disease and enhancement is hopelessly muddled.</p>
<p>So, while the scientists defending the first enhanced baby may be right that this is a moral good, unlike previous debaters they have given society no walls or barriers that allow us to confidently walk on to this new slippery slope. It is just dodging responsibility to say that “<a href="https://apnews.com/4997bb7aa36c45449b488e19ac83e86d">society will decide what to do next,</a>” as did He, or to say that the research “<a href="https://apnews.com/4997bb7aa36c45449b488e19ac83e86d">is justifiable,</a>” without defining a limit, as did Harvard University’s George Church. </p>
<p>For a responsible debate, participants must state not only their conclusion about this particular act of enhancement, but also where they will build a wall and, critically, how this wall will be maintained in the future.</p>
<p><em>This article was updated on November 29, 2018, to refer to He Jiankui by his last name.</em></p><img src="https://counter.theconversation.com/content/107677/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>John Evans does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A Chinese scientist has revealed he edited the DNA of twin girls born through in vitro fertilization. These girls are designed to be resistant to HIV. Is the edit a medical necessity or an enhancement?John Evans, Professor of Sociology, University of California San DiegoLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1076932018-11-27T00:14:44Z2018-11-27T00:14:44ZResearcher claims CRISPR-edited twins are born. How will science respond?<figure><img src="https://images.theconversation.com/files/247388/original/file-20181126-140507-159c1qx.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Chinese scientist He Jiankui of Shenzhen claims he helped make the world’s first genetically edited babies.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/compilation-six-ultrasound-scans-baby-twins-326022782?src=bE9JQBLryIVJYlvmSM1tLg-1-3">from www.shutterstock.com </a></span></figcaption></figure><p>Gene editing technology is revolutionising biology – and now twin human baby girls <a href="https://www.apnews.com/4997bb7aa36c45449b488e19ac83e86d">may be a living part of this story</a>. </p>
<p>Today several media outlets <a href="https://www.nature.com/articles/d41586-018-07545-0">report</a> that a team of scientists in China has <a href="https://www.technologyreview.com/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/">used CRISPR</a> to modify the DNA of healthy human embryos to genetically “vaccinate” against HIV infection.</p>
<p>This is the first reported case of humans born with CRISPR-modifed DNA. </p>
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<a href="http://theconversation.com/what-is-crispr-gene-editing-and-how-does-it-work-84591">What is CRISPR gene editing, and how does it work?</a>
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<p>The molecular scissors known as CRISPR (<a href="https://theconversation.com/what-is-crispr-gene-editing-and-how-does-it-work-84591">CRISPR/cas9</a> in full) allow scientists to modify DNA with high precision and greater ease than previous technologies. There are high hopes these molecular scissors may aid in curing diseases such as <a href="http://stm.sciencemag.org/content/10/449/eaao3240">cancer</a> or <a href="https://www.nature.com/articles/nature25164">other conditions</a> – but scientists around the world had agreed careful regulation was required before the technology was used in humans. </p>
<p>Now with this news, all eyes will be on the <a href="http://www.nationalacademies.org/gene-editing/2nd_summit/index.htm">Second International Summit on Human Genome Editing</a> taking place this week in Hong Kong. This meeting will hopefully lead to a renewed consensus for tighter control of CRISPR editing in human embryos.</p>
<h2>How has the babies’ genome been modified?</h2>
<p>According to <a href="https://www.technologyreview.com/s/612458/exclusive-chinese-scientists-are-creating-crispr-babies/">several reports</a>, researchers at the Southern University of Science and Technology in Shenzhen (China) have created the first gene-edited babies. </p>
<p>It’s important to note here the science has not been posted on a preprint server or published in a peer-reviewed journal – the usual standard applied to confirm new research is valid and ethically sound. However, Chinese medical documents posted online <a href="http://www.chictr.org.cn/showprojen.aspx?proj=32758">support the notion that a trial had been set up</a>, and the lead scientist involved (He Jiankui) has made a video statement. </p>
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<figcaption><span class="caption">Scientist He Jiankui of Shenzhen says he said he has altered DNA in human embryos, and that healthy twin girls are now at home with their parents.</span></figcaption>
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<p>In China the prevalence of HIV infection is high, and access to health care a serious public health concern. According to the <a href="http://www.chictr.org.cn/showprojen.aspx?proj=32758">medical document published online</a>, the study recruited HIV-positive men with HIV-negative female partners, and who were willing to participate in an IVF program and allow embryos to be edited with CRISPR. </p>
<p>The team led by Jiankui He focused on removing a gene called CCR5, critical for the HIV virus to enter into the cells. The goal was to genetically “vaccinate” the babies against HIV infection. They modified the DNA of the embryos, verified the molecular scissors were truly on target and implanted edited embryos in the mother’s body. </p>
<p>Reports indicate that gene-edited <a href="https://www.apnews.com/4997bb7aa36c45449b488e19ac83e86d">twin girls have now been born</a>. In one of the twins both copies of the CCR5 gene are said to be modified, and for the other one only one copy is modified.</p>
<p>We have little to no details on how this was performed and we must take these reports with a lot of caution.</p>
<h2>Serious ethical concerns</h2>
<p>CRISPR is easier to use and more precise than previous methods, but it is not a perfect technology. It can lead to unintended consequences, such as affecting other genes (“off-target” effects) or making multiple modifications of the gene we are aiming to modify (“on-target” effects). There is an <a href="https://theconversation.com/crispr-cas9-gene-editing-scissors-are-less-accurate-than-we-thought-but-there-are-fixes-100007">ongoing discussion as to how widespread “off target” and “on-targets” modifications</a> are, and what the unintended consequences of these effects may be.</p>
<p>Modifying embryos may have lasting consequences: not only would affected children have had their genome modified, but their future offspring could also carry these genetic modifications. To date we do not know what the long term effects of CRISPR-modification of human DNA are.</p>
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<a href="http://theconversation.com/worlds-first-gene-edited-babies-premature-dangerous-and-irresponsible-107642">World's first gene-edited babies? Premature, dangerous and irresponsible</a>
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<p>Given the massive, multi-generational implications of editing embryos, we argue it should only be considered in cases where the modification would cure an existing disease and for which no other, lower-risk solution is available and when potential side effects are known.</p>
<p>Controversially, in the study being discussed, the edit does not cure a pre-existing disease, and we already have existing alternatives to prevent HIV infection and limit its clinical progression to AIDS. </p>
<p>The reports fall in the grey area between attempts to cure diseases, and the dreaded “<a href="https://www.theguardian.com/science/2017/jan/08/designer-babies-ethical-horror-waiting-to-happen">designer baby</a>” scenario, where humans could be modified for benefits unrelated to health (potentially expanding to include intelligence, aesthetics and more).</p>
<h2>An important, broader discussion is taking place</h2>
<p>As soon as CRIPSR technology was widely available, it was a matter of when, rather than if, it would be used on humans. The <a href="https://link.springer.com/article/10.1007/s13238-015-0153-5">first modification of human embryos</a> was reported by another Chinese team in May 2015. Those embryos were not viable, but it sparked an intense debate about the ethics of such modifications.</p>
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Read more:
<a href="http://theconversation.com/human-embryo-crispr-advances-science-but-lets-focus-on-ethics-not-world-firsts-81956">Human embryo CRISPR advances science but let's focus on ethics, not world firsts</a>
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<p>This led to the the Chinese Academy of Sciences (CAS), the Royal Society (RS), and the U.S. National Academy of Sciences (NAS) and U.S. National Academy of Medicine (NAM) coming together to organise an International Summit on Human Gene Editing in December 2015 in Washington, DC.</p>
<p>Editing human embryos was the topic discussed at that meeting. At the time, <a href="http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12032015a">a published conclusion stated</a> that: </p>
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<p>it would be irresponsible to proceed with any clinical use of human embryos editing unless and until (i) the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives, and (ii) there is broad societal consensus about the appropriateness of the proposed application.</p>
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<p>The committee also noted: </p>
<blockquote>
<p>these criteria have not been met for any proposed clinical use: the safety issues have not yet been adequately explored; the cases of most compelling benefit are limited.</p>
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<p>CRISPR pioneers Jennifer Doudna and Emmanuelle Charpentier rightly noted <a href="http://science.sciencemag.org/content/346/6213/1258096">the need for a rational public discourse</a> on the use of the technology. However, this rational debate can only take place if all scientists play their part and ensure that all experiments are done in the public interest. </p>
<p>In Australia human embryo editing for reproductive purpose <a href="https://nhmrc.gov.au/about-us/publications/embryo-research-licensing-key-terms">is strictly prohibited</a>.</p>
<h2>A race for attention</h2>
<p>Based on the information currently available, it is difficult not to consider this latest experiment as anything but an attempt to win a “race” and grab attention. </p>
<p>The Southern University of Science and Technology has now <a href="https://www.sustc.edu.cn/news_events_/5524">released a statement</a> that it gave no permission to Jiankui He for his experiment, that he has been on leave since February, and that they believe the experiment violates academic ethics and academic norms. </p>
<p>Rice University has also <a href="https://www.statnews.com/2018/11/26/rice-university-opens-investigation-into-researcher-who-worked-on-crisprd-baby-project/">opened an investigation</a> into Michael Deem (a bioengineering professor at Rice and previous supervisor of He) and his possible role in the study.</p>
<p>Whether He’s claims are true or not, this whole situation is a disservice to the entire field of research, and to potential future recipients of CRISPR-based therapies.</p><img src="https://counter.theconversation.com/content/107693/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Dimitri Perrin receives funding from the Australian Research Council (ARC).</span></em></p><p class="fine-print"><em><span>Gaetan Burgio receives funding from the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC), the National Collaborative Research Infrastructure Strategy (NCRIS) via the Australian Phenomics Network (APN) and the Natural Science Foundation in China (NSFC).</span></em></p>We don't know anything about the health of the baby girls who are reported to have been born. But it's clear scientists around the world are shocked.Dimitri Perrin, Senior Lecturer, Queensland University of TechnologyGaetan Burgio, Geneticist and Group Leader, The John Curtin School of Medical Research, Australian National UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1076432018-11-26T20:23:33Z2018-11-26T20:23:33ZGene-edited babies: China wants to be the world leader, but at what cost?<figure><img src="https://images.theconversation.com/files/247279/original/file-20181126-140537-6bgiwe.png?ixlib=rb-1.1.0&amp;rect=0%2C26%2C1500%2C929&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Embryos with eight cells. </span> <span class="attribution"><a class="source" href="https://www.nature.com/articles/nature23305">DOI:10.1038/nature23305</a></span></figcaption></figure><p><a href="https://www.apnews.com/4997bb7aa36c45449b488e19ac83e86d">Recent claims</a> of the world’s first gene-edited babies have sparked a <a href="https://theconversation.com/worlds-first-gene-edited-babies-premature-dangerous-and-irresponsible-107642">strong response</a>, to say the least. In particular, the Southern University of Science and Technology, which employs the researcher involved, He Jiankui, stated in a <a href="http://sustc.edu.cn/en/info_focus/2871">press release</a> that they were not aware of his work, that it took place off campus, and that it was a case of potential scientific misconduct that would not go unaddressed. </p>
<p>The striking news marks a sharp increase in the controversy surrounding human genome editing. But this isn’t the <a href="https://link.springer.com/article/10.1007%2Fs10815-016-0710-8">first time</a> a Chinese team has used the CRISPR technique on human embryos in a way that few researchers from other countries have attempted, and the country has claimed <a href="https://www.wired.com/story/crispr-base-editing-first-china/">several firsts</a> in the field.</p>
<p>The debate about China’s advances in this area broke out of laboratories and scientific circles a few years ago. In a 2015 New York Times article, <a href="https://www.nytimes.com/2015/06/30/science/a-scientific-ethical-divide-between-china-and-west.html">“A scientific ethical divide between China and West”</a>, Yi Huso, director of research at the Chinese University of Hong Kong Centre for Bioethics, stated: “I don’t think China wants to take a moratorium […] People are saying they can’t stop the train of mainland Chinese genetics because it’s going too fast.”</p>
<p>However, there are some important things to understand about the state of human genome editing in China today. First, access to <a href="https://doi.org/10.1155/2013/934567">surplus embryos</a> in China isn’t much easier than anywhere else. On average, 83% of Chinese couples going through IVF procedures decide to keep their embryos up to three years after giving birth to a child. In the United States, approximately 62% of American couples keep their embryos up to five years after a birth. In France, of 220,000 frozen surplus embryos, just 20,000 can be made available for research, and less than 10% of those have been effectively used.</p>
<h2>The new technological race</h2>
<p>But China has entered a “genome editing” race among great scientific nations and its progress didn’t come out of nowhere. China has invested heavily in the natural-sciences sector over the past 20 years. The <a href="https://www.ncbi.nlm.nih.gov/pubmed/15583678">Ninth Five-Year Plan</a> (1996-2001) mentioned the crucial importance of biotechnologies. The current <a href="http://www.gov.cn/zhengce/content/2016-08/08/content_5098072.htm">Thirteenth Five-Year Plan</a> is even more explicit. It contains a section dedicated to “developing efficient and advanced biotechnologies” and lists key sectors such as “genome-editing technologies” intended to “put China at the bleeding edge of biotechnology innovation and become the leader in the international competition in this sector”.</p>
<p>Chinese embryo research is regulated by a <a href="http://www.moh.gov.cn/mohbgt/pw10303/200804/18593.shtml">legal framework</a>, the “technical norms on human-assisted reproductive technologies”, published by the Science and Health Ministries. The guidelines theoretically forbid using sperm or eggs whose genome have been manipulated for procreative purposes. However, it’s hard to know how much value is actually placed on this rule in practice, especially in China’s intricate institutional and political context.</p>
<p>In theory, three major actors have authority on biomedical research in China: the Science and Technology Ministry, the Health Ministry, and the Chinese Food and Drug Administration. In reality, other agents also play a significant role. Local governments interpret and enforce the ministries’ “recommendations”, and their own interpretations can lead to <a href="https://halshs.archives-ouvertes.fr/halshs-00694096/document">significant variations</a> in what researchers can and cannot do on the ground. The Chinese National Academy of Medicine is also a powerful institution that has its own network of hospitals, universities and laboratories.</p>
<p>Another prime actor is involved: the health section of the People’s Liberation Army (PLA), which has its own biomedical faculties, hospitals and research labs. The PLA makes its own interpretations of the recommendations and has proven its ability to work with the private sector on gene editing projects. In January 2018, the Wall Street Journal <a href="https://www.wsj.com/articles/china-unhampered-by-rules-races-ahead-in-gene-editing-trials-1516562360">reported that</a> 86 patients had been enlisted into a clinical trial in an attempt to cure cancer. A Chinese start-up, Anhui Kedgene Biotechnology, was involved in this partnership with the PLA hospital 105, in Hefei province.</p>
<p>It is still to early to tell what is really at stake here. The <a href="http://www.sixthtone.com/news/1438/chinese-scientists-rising-star-implodes">Ng-Ago precedent</a> should make everyone cautious of such major announcements: even published articles can be retracted, and peer-reviewed research amended. This announcement is not even at that stage. And the media timing is just a bit too perfect, as Antonio Regalado, MIT Technology Review’s senior biomedicine editor, stated in a tweet: </p>
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<p>This is clearly not the end of the story, just another dramatic step into the new age of gene editing.</p><img src="https://counter.theconversation.com/content/107643/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Guillaume Levrier has received funding from the French National Research Agency.</span></em></p>China is pushing hard to lead a genome editing race.Guillaume Levrier, Doctorant - CEVIPOF (Centre de recherches politiques de Sciences Po), Sciences Po – USPCLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1076422018-11-26T16:55:49Z2018-11-26T16:55:49ZWorld's first gene-edited babies? Premature, dangerous and irresponsible<figure><img src="https://images.theconversation.com/files/247294/original/file-20181126-140519-1oixr4d.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/genetic-engineering-gmo-gene-manipulation-concept-1179311575?src=_WauTQbzcsws-jES3kwLtQ-2-54">Vchal/Shutterstock</a></span></figcaption></figure><p>A scientist in China <a href="https://www.apnews.com/4997bb7aa36c45449b488e19ac83e86d">claims to have</a> produced the world’s first genome-edited babies by altering their DNA to increase their resistance to HIV. Aside from the lack of verifiable evidence for this non peer-reviewed claim, this research is premature, dangerous and irresponsible.</p>
<p>He Jiankui from the Southern University of Science and Technology in Shenzhen (which has reportedly since <a href="https://www.technologyreview.com/s/612466/the-chinese-scientist-who-claims-he-made-crispr-babies-has-been-suspended-without-pay/">suspended him</a>) said he edited the DNA of seven embryos being used for fertility treatment, so far resulting in the birth of one set of twin girls. He says he used the tool known as <a href="https://theconversation.com/explainer-crispr-technology-brings-precise-genetic-editing-and-raises-ethical-questions-39219">CRISPR</a> to delete the embryos’ CCR5 gene (C-C motif chemokine receptor 5), mutations in which are linked to resistance to HIV infection. </p>
<p>If true, this is a significant advance in genetic science, but there are some very serious problems with this news. First, the research has not yet been published in a peer-reviewed journal so we cannot be sure of the exact details of what has been done. Instead, the scientist made the claims to the <a href="https://www.apnews.com/4997bb7aa36c45449b488e19ac83e86d">Associated Press</a> news organisation, and the journalists involved haven’t been able to independently verify them. The parents of the allegedly gene-edited babies declined to be interviewed or identified.</p>
<p>Second, we know there can be <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5819596/">significant problems</a> with using existing gene-editing technology <a href="https://theconversation.com/scientists-edit-human-embryos-to-safely-remove-disease-for-the-first-time-heres-how-they-did-it-81925">on human embryos</a>. The main two issues are <a href="https://www.newscientist.com/article/mg23331174-400-mosaic-problem-stands-in-the-way-of-gene-editing-embryos">mosaicism</a>, where the edited DNA does not appear in every cell of the embryo, and off-target effects, where other parts of the genome may also have been edited with unknown consequences.</p>
<p>Before genome editing becomes a clinical treatment, it is essential that scientists resolve both of these issues and eliminate other potential adverse effects on the embryo. We need comprehensive studies to show that genome editing is not going to cause harm to the future people it helps create. Any children born as a result of genome editing will also need long-term follow up. It would be vital to see the preliminary work that He has done to confirm that his technique has eliminated mosaicism and off-target effects, and it is surprising that he has not published this.</p>
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<p>There is also a question over why gene-editing was used to tackle the particular issue of HIV transmission in this case. The reports suggest that the couples involved in the study were made up of HIV-positive men who had the infection under control and HIV-negative women. The risk of transmission of HIV for these couples would have been negligible, and there are <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4779710/">well-established ways</a> to prevent HIV transmission to the offspring of HIV-positive couples.</p>
<p>Finally, there is the wider ethical debate, which the scientist in this case has chosen to ignore. I was a member of the Nuffield Council on Bioethics working group. We spent 20 months examining all aspects of genome editing and <a href="http://nuffieldbioethics.org/project/genome-editing-human-reproduction">published our report</a> this summer. Our conclusion was that we needed a public debate before gene editing on embryos was carried out because this procedure takes reproduction to a new level.</p>
<h2>Do we really need gene editing?</h2>
<p>Most reports suggest that the potential main use of genome editing would be <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4492683/">therapeutic genome editing</a> to prevent the transmission of genetic diseases, such as cystic fibrosis. In most cases, couples at risk of transmitting a genetic disease to their children are able to prevent transmission using established techniques of screening before birth or even before an embryo is implanted via IVF. So perhaps editing embryos for therapeutic reasons is not the way forward.</p>
<p>But genome editing could also more controversially used for <a href="https://theconversation.com/why-the-case-against-designer-babies-falls-apart-45256">genetic enhancements</a>, such as ensuring children have a particular desirable characteristic such as a certain eye colour. This raises even more ethical questions.</p>
<p>We also need legislation. In the UK, for example, the use of genome editing would be regulated by the Human Fertilisation and Embryology Authority, and would currently be illegal. Before this technique becomes a treatment, governments need to pass laws that will control and regulate it otherwise it could easily be misused.</p>
<p>With all this in mind, any research in this area needs to be peer-reviewed and published in the scientific literature, with all the necessary preliminary work, so that we can make a valued analysis of the technique. In bypassing this process, He has made our job much harder.</p><img src="https://counter.theconversation.com/content/107642/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Joyce Harper does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>A Chinese scientist claims to have edited human DNA to make us more resistant to HIV. Here's why that's not good news.Joyce Harper, Professor of Reproductive Science, UCLLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1044902018-10-24T04:27:46Z2018-10-24T04:27:46ZTweaking just a few genes in wild plants can create new food crops – but let's get the regulation right<figure><img src="https://images.theconversation.com/files/240008/original/file-20181010-72103-1ee4t5v.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">The tomatoes we eat have been carefully bred over generations, but now we can tap into wild varieties.</span> <span class="attribution"><a class="source" href="https://pixabay.com/en/tomato-agriculture-dirt-organic-2450370/">Pixabay/go_see</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span></figcaption></figure><p>The crops we rely on today have been bred over thousands of years to enhance certain characteristics. For example, sweetcorn started life as a wild grass called <a href="http://maize.uga.edu/index.php?loc=ancestors">teosinte</a>.</p>
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<p>But every time we select for a trait through breeding – such as repeatedly crossing selected plants to produce bigger fruits – we lose genetic diversity which is the essential variation for other traits like disease resistance. This leaves our crops vulnerable to pests and disease.</p>
<p>Precise gene editing technologies could offer a solution.</p>
<p>CRISPR gene editing has been successfully used to <a href="https://www.nature.com/articles/nbt.4272">re-domesticate wild tomato plants</a>. One research group edited only six genes and produced a commercially sized fruit in a wild relative of tomato, <a href="http://eol.org/pages/590239/overview"><em>Solanum pimpinellifolium</em></a>. Another group <a href="https://www.nature.com/articles/nbt.4273">achieved a similar result</a> by editing only four genes.</p>
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Read more:
<a href="http://theconversation.com/a-fresh-opportunity-to-get-regulation-and-engagement-right-the-case-of-synthetic-biology-102190">A fresh opportunity to get regulation and engagement right – the case of synthetic biology</a>
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<p>As a society we need to work out how such technology and plants will be regulated to ensure safety and acceptability.</p>
<h2>The new domestication</h2>
<p>The new approach, termed “<em>de novo</em> domestication” or “new domestication”, allows the genetic diversity of the wild plant to feature in a new crop. These new tomato lines retain all of the diversity of their ancestors, providing protection against disease.</p>
<p>They <a href="https://www.nature.com/articles/d41586-018-06915-y">taste good</a> too, apparently.</p>
<p>This was possible thanks to years of painstaking research into the genes that underpin the essential traits related to domestication. Without this, scientists wouldn’t know which genes to target and edit.</p>
<p>Some of the genes were identified by crossing plants with different traits (like large versus small fruits). Others were discovered by comparing wild relatives with domesticated plants.</p>
<h2>Could we do this with other wild species?</h2>
<p>We currently rely on very few plant species for the majority of the world’s food production. More than half of our plant-derived energy intake comes from <a href="http://www.fao.org/3/a-w7324e.pdf">just three grasses</a> (wheat, rice and corn). Gene editing could provide a way to expand this.</p>
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Read more:
<a href="http://theconversation.com/fewer-crops-are-feeding-more-people-worldwide-and-thats-not-good-86105">Fewer crops are feeding more people worldwide – and that's not good</a>
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<p>Showing the broader value of the tomato approach described above, <a href="https://www.nature.com/articles/s41477-018-0259-x">another research group</a> applied the same method to an orphan crop <em>Physalis pruinosa</em> (known as the ground cherry). Orphan crops are those that have been neglected and escaped modern agriculture for various reasons. They receive little investment, research or breeding effort.</p>
<p>The researchers hope the ground cherry will one day find its place alongside the strawberry, blueberry, blackberry and raspberry in large-scale agriculture.</p>
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<a href="https://images.theconversation.com/files/240007/original/file-20181010-72103-1kvsas3.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/240007/original/file-20181010-72103-1kvsas3.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/240007/original/file-20181010-72103-1kvsas3.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=324&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/240007/original/file-20181010-72103-1kvsas3.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=324&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/240007/original/file-20181010-72103-1kvsas3.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=324&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/240007/original/file-20181010-72103-1kvsas3.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=407&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/240007/original/file-20181010-72103-1kvsas3.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=407&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/240007/original/file-20181010-72103-1kvsas3.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=407&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Ground cherry could be a new berry crop.</span>
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<p>The “<em>de novo</em> domestication” approach potentially provides a way to domesticate any edible wild plant. With an estimated <a href="https://pfaf.org/user/edibleuses.aspx">20,000 known edible species</a>, the possibilities for domestication could be extraordinary – particularly in Australia, where broad, economically successful crop domestication of native foods has been mostly limited to the <a href="http://www.abc.net.au/news/2017-07-04/bush-tucker-bible-cataloguing-australias-unique-food-products/8676294">macadamia nut</a>.</p>
<h2>Gene sequencing getting cheaper</h2>
<p>To create new crops, we need good working knowledge of the gene targets, and the genome sequence (which contains the complete code of all genes inside each cell) of the plant species that we want to domesticate.</p>
<p>Genome sequencing used to cost many millions of dollars and require massive research teams. It’s now increasingly cheap and routine. </p>
<p>Our understanding of the target genes comes largely from studies of major agricultural crops. Some domestication genes will only work in species that are closely related to the crop in which they were discovered.</p>
<p>Versions of the domestication genes targeted in the tomato studies are found in many plant species, so the approach might well work in more distantly related species too.</p>
<h2>How should we regulate this?</h2>
<p>We should be fostering this kind of innovation, but we need to do it safely. </p>
<p>Worldwide, policymakers have wrestled with the implications of the new genetic tools. Debate has sprung up around how to regulate genome editing, compared with existing genetic modification methods.</p>
<p>Editing genes in a crop is different to traditional genetic modification, or <a href="https://www.scientificamerican.com/article/transgenics-a-new-breed-of-crops/">transgenics</a> – in which a gene from a different species is inserted into a plant. </p>
<p>In contrast to both of these approaches, classic crop breeding has relied on random processes like irradiation to induce new genetic diversity. CRISPR editing is similar but more efficient and precise, because it targets a specific desired mutation.</p>
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<p>In July, European courts <a href="https://www.nature.com/articles/d41586-018-05814-6">ruled</a> that edited plants fall under the same regulation as transgenics. This places them under very strict regulations that create significant hurdles to enter the market, potentially driving talent and funding out of Europe.</p>
<p>In contrast, the US Department of Agriculture (USDA) <a href="https://www.usda.gov/media/press-releases/2018/03/28/secretary-perdue-issues-usda-statement-plant-breeding-innovation">said</a> it would not regulate genome-edited crops.</p>
<h2>A balanced approach</h2>
<p>A reasonable balance between these two regulatory approaches is probably the most sensible way forward. Genome editing shouldn’t completely escape regulation. </p>
<p>If it can be demonstrated that the edited plant doesn’t contain any new genes (including CRISPR machinery) then the regulation should be much less stringent than for transgenics, because the changes are so similar to conventional plant breeding. Sequencing the genome of the edited crop is a good way to provide evidence of this.</p>
<p>In Australia, genetically modified organisms are regulated by the Office of the Gene Technology Regulator (<a href="http://www.ogtr.gov.au/">OGTR</a>). The current legislation <a href="http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/newtechnologies-htm">defines genetic modification very broadly</a>, but is <a href="http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/newtechnologies-htm">under review</a>. South Australia is an exception to this, with a <a href="http://www.pir.sa.gov.au/primary_industry/genetically_modified_gm_crops">ban</a> on genetically modified crops.</p>
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Read more:
<a href="http://theconversation.com/organic-farming-with-gene-editing-an-oxymoron-or-a-tool-for-sustainable-agriculture-101585">Organic farming with gene editing: An oxymoron or a tool for sustainable agriculture?</a>
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<p>Ideally, regulation should focus more on questions around the types of genetic modifications that we should allow in our crops than the way that they were introduced and where they came from.</p>
<p>But edited organisms shouldn’t be completely excluded from regulation. Evidence should be requested, and provided, that new crops are functionally equivalent to the products of conventional breeding and the subsequent approval process should reflect this.</p>
<p>The primary priority for policymakers and regulators is to ensure crop safety. Maintaining an open and transparent dialogue will be crucial so that the public can trust the decisions.</p><img src="https://counter.theconversation.com/content/104490/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>James Hereward receives funding from the Cotton Research and Development Corporation (CRDC). The project investigates the evolution of herbicide resistance in weeds.</span></em></p><p class="fine-print"><em><span>Caitlin Curtis is affiliated with the Queensland Genomic Health Alliance and the University of Queensland Genomics in Society Initiative.</span></em></p>Gene editing of wild plants can help us tap into new sources of food. But we need to make sure it's safe – and that demands some careful regulation.James Hereward, Research fellow, The University of QueenslandCaitlin Curtis, Research fellow, Centre for Policy Futures (Genomics), The University of QueenslandLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1045582018-10-14T19:06:40Z2018-10-14T19:06:40ZBoyer Lectures: gene therapy is still in its infancy but the future looks promising<figure><img src="https://images.theconversation.com/files/240370/original/file-20181012-119132-1l8k67h.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Determining the structure of the DNA was the beginning of the gene therapy journey.</span> <span class="attribution"><span class="source">from shutterstock.com</span></span></figcaption></figure><p><em>This year marks the 60th anniversary of the ABC’s Boyer Lectures. Delivered by Professor John Rasko, the 2018 <a href="http://about.abc.net.au/press-releases/life-re-engineered-abc-boyer-lectures-explore-how-gene-therapy-will-change-what-it-means-to-be-human/">Life Engineered</a> lectures explore ethical and other issues around gene therapy and related technologies, and their potential to cure disease, prolong life and change the course of human evolution.</em> </p>
<p><em>The first lecture will be broadcast on RN’s <a href="http://www.abc.net.au/radionational/programs/bigideas/">Big Ideas</a> at 8pm tonight. In light of this, we’ve asked Merlin Crossley to explain what gene therapy actually is and how we got to where we are with it.</em></p>
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<p>Over the last few centuries, infectious diseases have been understood and tackled, through advances in sanitation, anti-microbial medications and vaccination. One day we may also be able to tackle genetic diseases – lifelong conditions arising from mutations that we inherit from our ancestors or that occur during our development.</p>
<p>We’re over the foothills but we still have mountains to climb in treating genetic diseases.</p>
<h2>Step 1 – understanding genetic disease</h2>
<p>The key step to tackling infectious diseases was to truly define the nature of the microorganisms that caused them. Similarly, with genetic diseases the first step was to understand and define the nature of a gene. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/240360/original/file-20181012-154583-158hjmi.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/240360/original/file-20181012-154583-158hjmi.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/240360/original/file-20181012-154583-158hjmi.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=424&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/240360/original/file-20181012-154583-158hjmi.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=424&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/240360/original/file-20181012-154583-158hjmi.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=424&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/240360/original/file-20181012-154583-158hjmi.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=533&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/240360/original/file-20181012-154583-158hjmi.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=533&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/240360/original/file-20181012-154583-158hjmi.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=533&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">Our red blood cells carry oxygen with the help of the protein haemoglobin.</span>
<span class="attribution"><span class="source">shutterstock.com</span></span>
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<p>Scientists, including Watson, Crick and Franklin, <a href="https://www.sciencehistory.org/historical-profile/james-watson-francis-crick-maurice-wilkins-and-rosalind-franklin">determined the structure of DNA</a> in 1953. Gradually it became clear that a gene was a stretch of DNA that encoded a functional product, such as the oxygen-carrying protein haemoglobin. </p>
<p>Around the same time in 1949, US chemist <a href="https://www.britannica.com/biography/Linus-Pauling">Linus Pauling demonstrated</a> that the disease sickle cell anaemia was caused by a chemical change in haemoglobin. He called this the first “molecular disease”. With the advent of DNA sequencing in the 1970s, the <a href="https://ghr.nlm.nih.gov/gene/HBB">actual mutation</a> in the globin gene was identified. </p>
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Read more:
<a href="http://theconversation.com/explainer-one-day-science-may-cure-sickle-cell-anaemia-28153">Explainer: one day science may cure sickle cell anaemia</a>
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<p>Rapidly after this, the genetic lesions responsible for other inherited diseases – such as haemophilia, cystic fibrosis and muscular dystrophy – were identified. From this moment on, the idea of replacing defective genes or correcting them captured people’s imaginations, and this is the basis of what we now call “gene therapy”.</p>
<h2>Step 2 – replacing defective genes</h2>
<p>Patients suffering from genetic diseases either have a defective gene or may altogether lack a key gene. In the early stages of gene therapy there was no way of correcting genes, so researchers focused on supplementing the body with a replacement gene. </p>
<p>In the 1980s, recombinant DNA technology (where chosen DNA molecules are transferred between individual organisms) was developed by harnessing the miniature machinery bacteria and viruses use to move DNA around. This allowed researchers to isolate individual human genes and encapsulate them in harmless viruses to deliver them into human cells.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/240366/original/file-20181012-119138-1864f24.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/240366/original/file-20181012-119138-1864f24.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/240366/original/file-20181012-119138-1864f24.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=303&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/240366/original/file-20181012-119138-1864f24.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=303&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/240366/original/file-20181012-119138-1864f24.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=303&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/240366/original/file-20181012-119138-1864f24.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=381&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/240366/original/file-20181012-119138-1864f24.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=381&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/240366/original/file-20181012-119138-1864f24.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=381&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">In somatic gene therapy, the therapeutic genes can be put inside a virus and transported into the body.</span>
<span class="attribution"><span class="source">shutterstock.com</span></span>
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<p>It was possible to get the genes into certain blood cells and other accessible tissues. This process was termed somatic gene therapy (from “soma” meaning, “the body”) and was distinct from <a href="https://www.genome.gov/10004764/germline-gene-transfer/">germline gene therapy</a> where eggs or sperm, or early embryos, would be modified and whole people and their offspring changed forever. </p>
<p>Human germline gene therapy is widely outlawed and there is no evidence it has ever been seriously attempted.</p>
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<em>
<strong>
Read more:
<a href="http://theconversation.com/human-genome-editing-report-strikes-the-right-balance-between-risks-and-benefits-72951">Human genome editing report strikes the right balance between risks and benefits</a>
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<p>But <a href="https://www.ncbi.nlm.nih.gov/pubmed/8976157">somatic gene therapy</a> has been attempted and, in some cases, has been successful. Viruses really can be made harmless and filled with human DNA, which they deliver into the patient’s cells. </p>
<p>A handful of people have now been successfully treated in this way for <a href="https://presse.inserm.fr/en/new-gene-therapy-success-in-beta-thalassemia-22-patients-treated-in-france-united-states-thailand-and-australia/31149/">haemoglobin deficiencies</a>, <a href="https://www.haemophilia.org.au/publications/national-haemophilia/2018/no-201-march-2018/gene-therapy">haemophilia</a>, and for immune disorders, such as so-called <a href="https://www.webmd.com/baby/news/20171209/gene-therapy-may-be-cure-for-bubble-boy-disease#1">“bubble boy” disease </a> (where victims are particularly vulnerable to infectious diseases).</p>
<h2>Step 3 – improving replacement gene therapy</h2>
<p>Attempts at these forms of gene replacement therapy began in the 1990s but <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3681190/">early results</a> were disappointing. It proved difficult to get the genes into enough human cells, and when the genes did get in they were often <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC289175/">turned off</a> after a few weeks.</p>
<p>More worryingly, it was not possible to determine where in the chromosome the replacement gene would land. Often it integrated harmlessly in an unimportant part of the genome, but sometimes it landed near to, and activated, growth control genes called “oncogenes” that drive cellular proliferation and cancer. </p>
<p>Some of the <a href="https://www.newscientist.com/article/dn2878-miracle-gene-therapy-trial-halted/">first children treated</a> for “bubble boy” disease developed leukemias. These leukemias were treatable, but the complications, together with immune reactions, such as led to the death of <a href="https://en.wikipedia.org/wiki/Jesse_Gelsinger">Jesse Gelsinger</a> in an early gene therapy trial in 2000, led to caution.</p>
<p>Over the years, researchers have developed better viruses, systematically improved the gene delivery protocols and found control switches that aren’t turned off by our body’s anti-viral response. In recent gene therapy trials for <a href="https://www.nejm.org/doi/full/10.1056/NEJMoa1708538">haemophilia</a>, <a href="http://www.bloodjournal.org/content/130/Suppl_1/355?sso-checked=true">haemoglobin</a> disorders, and also for specific inherited forms of <a href="https://mashable.com/2018/03/24/gene-therapy-blindness-treatment/">blindness</a>, many of the patients treated have benefited.</p>
<h2>Step 4 – gene correction</h2>
<p>The advent of new techniques, most notably CRISPR-mediated gene editing, has led to the idea of correcting a mutant gene rather than adding a replacement. CRISPR is a system that bacteria use to identify and cut invading viral DNA. It has now been used by researchers to direct DNA modification machines to chosen human genes. </p>
<p><iframe id="tc-infographic-229" class="tc-infographic" height="580px" src="https://cdn.theconversation.com/infographics/229/1e1ccd9abbd9a92604e144561050c08a9c49d8b3/site/index.html" width="100%" style="border: none" frameborder="0"></iframe></p>
<p>We can now develop miniature chemical tools to convert harmful mutations back into normal sequences. News that this technology was being used on <a href="https://link.springer.com/article/10.1007%2Fs13238-015-0153-5">human embryos in China</a> created a storm of controversy but so far those experiments have only involved embryos that were known to be non-viable and the research has been purely experimental.</p>
<p>Elsewhere researchers aren’t exploring modifications of whole embryos. Instead the somatic gene therapy approach is being followed, for example, to see if genes can be corrected in a high proportion of <a href="https://www.sciencedirect.com/science/article/pii/S1525001616453323">blood stem cells</a> and whether these cells can then be transplanted back into the patient to cure their disease.</p>
<h2>Step 5 – The future</h2>
<p>We will soon see an increasing number of patients helped by both gene replacement therapy and by CRISPR-mediated gene correction. But the work is likely to be focused on a few specific diseases rather than there being a broad advance across all genetic diseases. </p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/240385/original/file-20181012-119114-19u0x3q.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/240385/original/file-20181012-119114-19u0x3q.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/240385/original/file-20181012-119114-19u0x3q.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=629&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/240385/original/file-20181012-119114-19u0x3q.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=629&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/240385/original/file-20181012-119114-19u0x3q.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=629&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/240385/original/file-20181012-119114-19u0x3q.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=791&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/240385/original/file-20181012-119114-19u0x3q.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=791&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/240385/original/file-20181012-119114-19u0x3q.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=791&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
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<span class="caption">An increasing number of patients will soon be helped by CRISPR-mediated gene correction.</span>
<span class="attribution"><span class="source">shutterstock.com</span></span>
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<p>The diseases treated first will share some key characteristics: the genetic defects would be well-understood; they must affect a tissue we can get at easily (blood will be easier than brains and bones); the conditions would be serious and have no other effective treatments. </p>
<p>And they must be so costly in terms of human suffering and economic burdens that a complex and expensive treatment such as gene therapy becomes a viable option. </p>
<p>This means common blood and immune disorders are likely to feature in the first generation trials. Cancer is also a genetic disease, but one typically caused by mutations that accumulate in our cells over time rather than by inherited mutations, and somatic gene therapy, in the form of immunotherapy, involving enhancing the capacity of our immune systems to fight cancer may also become common. </p>
<p>A Nobel Prize was <a href="https://www.nytimes.com/2018/10/01/health/nobel-prize-medicine.html">just awarded</a> for anti-cancer immunotherapy, and it is likely that the genetic modification of the immune system will increasingly be used to treat cancers.</p>
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<p>
<em>
<strong>
Read more:
<a href="http://theconversation.com/how-two-1990s-discoveries-have-led-to-some-cured-cancers-and-a-nobel-prize-104221">How two 1990s discoveries have led to (some) cured cancers, and a Nobel Prize</a>
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<p>The age of gene therapy is arriving but it will be gradual, not sudden. But incrementally, more people will benefit from these treatments. </p>
<p>In the long term, as we all become aware of mutations we carry in our own genomes that may affect our offspring, there may be pressure to correct more and more genetic lesions. This will remain too risky and expensive for many years so gene therapy will likely remain a niche and specialist treatment for the foreseeable future.</p><img src="https://counter.theconversation.com/content/104558/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Merlin Crossley works for UNSW and receives funding from the Australian Research Council and National Health and Medical Research Council, and serves on the Trust of the Australian Museum, the Australian Science Media Centre, UNSW Press, UNSW Global, and is on the Editorial Board of The Conversation and of he journal Bioessays. </span></em></p>Once genetic lesions for diseases such as cystic fibrosis and haemophilia were identified, the idea of replacing or correcting defective genes grew into what we now call "gene therapy".Merlin Crossley, Deputy Vice-Chancellor Academic and Professor of Molecular Biology, UNSWLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1015852018-10-10T10:49:30Z2018-10-10T10:49:30ZOrganic farming with gene editing: An oxymoron or a tool for sustainable agriculture?<figure><img src="https://images.theconversation.com/files/233152/original/file-20180822-149463-1yjj5bp.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Many farmers cultivating organic crops believe that genetically modified crops pose threats to human health.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/organic-vegetables-on-wood-farmer-holding-529914715">mythja/Shutterstock.com</a></span></figcaption></figure><p>A University of California, Berkeley professor stands at the front of the room, delivering her invited talk about the potential of genetic engineering. Her audience, full of organic farming advocates, listens uneasily. She notices a man get up from his seat and move toward the front of the room. Confused, the speaker pauses mid-sentence as she watches him bend over, reach for the power cord, and unplug the projector. The room darkens and silence falls. So much for listening to the ideas of others.</p>
<p>Many organic advocates claim that genetically engineered crops are <a href="https://www.downtoearth.org/label-gmos/risks-genetic-engineering">harmful</a> to human health, the environment, and the farmers who work with them. Biotechnology advocates fire back that genetically engineered crops are <a href="https://doi.org/10.17226/23395">safe</a>, reduce insecticide use, and allow farmers in developing countries to produce enough food to feed themselves and their families. </p>
<p>Now, sides are being chosen about whether the new gene editing technology, CRISPR, is really just “<a href="https://usrtk.org/gmo/gmo-2-0-foods-coming-your-way-will-they-be-labeled/">GMO 2.0</a>” or a helpful <a href="https://doi.org/10.1016/j.pbi.2018.04.013">new tool</a> to speed up the plant breeding process. In July, the European Union’s Court of Justice <a href="http://curia.europa.eu/juris/document/document.jsf?text=&amp;docid=204387&amp;pageIndex=0&amp;doclang=EN&amp;mode=req&amp;dir=&amp;occ=first&amp;part=1&amp;cid=44391">ruled</a> that crops made with CRISPR will be classified as genetically engineered. In the United States, meanwhile, the regulatory system is <a href="https://www.usda.gov/media/press-releases/2018/03/28/secretary-perdue-issues-usda-statement-plant-breeding-innovation">drawing distinctions</a> between genetic engineering and specific uses of genome editing.</p>
<figure class="align-right ">
<img alt="" src="https://images.theconversation.com/files/233146/original/file-20180822-149490-24y18u.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/233146/original/file-20180822-149490-24y18u.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=394&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/233146/original/file-20180822-149490-24y18u.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=394&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/233146/original/file-20180822-149490-24y18u.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=394&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/233146/original/file-20180822-149490-24y18u.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=495&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/233146/original/file-20180822-149490-24y18u.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=495&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/233146/original/file-20180822-149490-24y18u.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=495&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">For many, perception of genetically modified foods has changed little from those of this protester dressed as a genetically altered ‘Killer Tomato’ marching through downtown San Diego, June 24, 2001.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Associated-Press-Domestic-News-California-Unite-/ef3ae3e1ede6da11af9f0014c2589dfb/5/0">Joe Cavaretta/AP Photo</a></span>
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<p>I am a plant molecular biologist and appreciate the awesome potential of both CRISPR and genetic engineering technologies. But I don’t believe that pits me against the goals of organic agriculture. In fact, biotechnology can help meet these goals. And while rehashing the arguments about genetic engineering seems counterproductive, genome editing may draw both sides to the table for a healthy conversation. To understand why, it’s worth digging into the differences between genome editing with CRISPR and genetic engineering.</p>
<h2>What’s the difference between genetic engineering, CRISPR and mutation breeding?</h2>
<p>Opponents argue that CRISPR is a <a href="https://foe.org/news/2017-01-usda-proposal-for-biotech-regulations-falls-short/">sneaky way</a> to trick the public into eating genetically engineered foods. It is tempting to toss CRISPR and genetic engineering into the same bucket. But even “genetic engineering” and “CRISPR” are too broad to convey what is happening on the genetic level, so let’s look closer.</p>
<p>In one type of genetic engineering, a gene from an unrelated organism can be introduced into a plant’s genome. For example, much of the <a href="http://bteggplant.cornell.edu/content/news/blog/director-general-bari-remarks-about-bt-brinjal">eggplant grown in Bangladesh</a> incorporates a gene from a common bacterium. This gene makes a protein called Bt that is harmful to insects. By putting that gene inside the eggplant’s DNA, the plant itself becomes lethal to eggplant-eating insects and <a href="https://doi.org/10.1126/sciadv.1600850">decreases the need for insecticides</a>. Bt is safe for humans. It’s like how chocolate makes dogs sick, but doesn’t affect us. </p>
<p>Another type of genetic engineering can move a gene from one variety of a plant species into another variety of that same species. For example, researchers identified a gene in wild apple trees that makes them resistant to <a href="https://www.apsnet.org/edcenter/intropp/lessons/prokaryotes/Pages/FireBlight.aspx">fire blight.</a>They <a href="https://doi.org/10.1371/journal.pone.0143980">moved that gene</a> into the “Gala Galaxy” apple to make it resistant to disease. However, this new apple variety has not been commercialized. </p>
<p>Scientists are unable to direct where in the genome a gene is inserted with traditional genetic engineering, although they use DNA sequencing to identify the location after the fact. </p>
<p>In contrast, CRISPR is a tool of precision.</p>
<p>Just like using the “find” function in a word processor to quickly jump to a word or phrase, the CRISPR molecular machinery finds a specific spot in the genome. It cuts both strands of DNA at that location. Because cut DNA is problematic for the cell, it quickly deploys a repair team to mend the break. There are two pathways for repairing the DNA. In one, which I call “CRISPR for modification,” a new gene can be inserted to link the cut ends together, like pasting a new sentence into a word processor. </p>
<p>In “CRISPR for mutation,” the cell’s repair team tries to glue the cut DNA strands back together again. Scientists can direct this repair team to change a few DNA units, or base pairs (A’s, T’s, C’s and G’s), at the site that was cut, creating a small DNA change called a mutation. This technique can be used to tweak the gene’s behavior inside the plant. It can also be used to silence genes inside the plant that, for example, are <a href="https://doi.org/10.1038/nbt.2969">detrimental to plant survival</a>, like a gene that increases susceptibility to fungal infections.</p>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/239543/original/file-20181005-72100-8199mg.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/239543/original/file-20181005-72100-8199mg.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/239543/original/file-20181005-72100-8199mg.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=370&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/239543/original/file-20181005-72100-8199mg.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=370&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/239543/original/file-20181005-72100-8199mg.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=370&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/239543/original/file-20181005-72100-8199mg.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=465&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/239543/original/file-20181005-72100-8199mg.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=465&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/239543/original/file-20181005-72100-8199mg.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=465&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">In genetic engineering, a new gene is added to a random location in a plant’s genome. CRISPR for modification also allows a new gene to be added to a plant, but targets the new gene to a specific location. CRISPR for mutation does not add new DNA. Rather, it makes a small DNA change at a precise location. Mutation breeding uses chemicals or radiation (lightning bolts) to induce several small mutations in the genomes of seeds. Resulting plants are screened for beneficial mutations resulting in desirable traits.</span>
<span class="attribution"><span class="source">Rebecca Mackelprang</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p><a href="https://books.google.com/books?hl=en&amp;lr=&amp;id=mDjLBAAAQBAJ&amp;oi=fnd&amp;pg=PP1&amp;dq=mutation+breeding&amp;ots=hOXPUt2p5H&amp;sig=qcnBWrcHGIayvZ6YifclAT2sjYk#v=onepage&amp;q=mutation%20breeding&amp;f=false">Mutation breeding</a>, which in my opinion is also a type of biotechnology, is already used in organic food production. In mutation breeding, radiation or chemicals are used to randomly make mutations in the DNA of hundreds or thousands of seeds which are then grown in the field. Breeders scan fields for plants with a desired trait such as disease resistance or increased yield. <a href="https://doi.org/10.1023/B:EUPH.0000014914.85465.4f">Thousands of new crop varieties</a> have been created and commercialized through this process, including everything from varieties of <a href="https://www.iaea.org/newscenter/news/quinoa-farmers-increase-yields-using-nuclear-derived-farming-practices">quinoa</a> to varieties of <a href="https://geneticliteracyproject.org/2013/11/27/popular-sweet-grapefruit-rio-red-a-product-of-unregulated-risky-process-of-mutagenesis/">grapefruit</a>. Mutation breeding is considered a <a href="https://www.ams.usda.gov/sites/default/files/media/NOP-PM-13-1-CellFusion.pdf">traditional breeding technique</a>, and thus is not an “<a href="https://www.ecfr.gov/cgi-bin/text-idx?SID=9c79a660d1d7414c48a7e1d257b00561&amp;mc=true&amp;node=pt7.3.205&amp;rgn=div5#se7.3.205_1200">excluded method</a>” for organic farming in the United States.</p>
<p>CRISPR for mutation is more similar to mutation breeding than it is to genetic engineering. It creates similar end products as mutation breeding, but removes the randomness. It does not introduce new DNA. It is a controlled and predictable technique for generating helpful new plant varieties capable of resisting disease or weathering adverse environmental conditions.</p>
<h2>Opportunity lost – learning from genetic engineering</h2>
<p>Most commercialized genetically engineered traits confer herbicide tolerance or insect resistance in corn, soybean or cotton. Yet many other engineered crops exist. While a few are grown in the field, most sit all but forgotten in dark corners of research labs because of the prohibitive expense of passing regulatory hurdles. If the regulatory climate and public perception allow it, crops with valuable traits like these could be produced by CRISPR and become common in our soils and on our tables.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/234342/original/file-20180830-195322-1t1cqjo.jpeg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/234342/original/file-20180830-195322-1t1cqjo.jpeg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/234342/original/file-20180830-195322-1t1cqjo.jpeg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=777&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/234342/original/file-20180830-195322-1t1cqjo.jpeg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=777&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/234342/original/file-20180830-195322-1t1cqjo.jpeg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=777&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/234342/original/file-20180830-195322-1t1cqjo.jpeg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=976&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/234342/original/file-20180830-195322-1t1cqjo.jpeg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=976&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/234342/original/file-20180830-195322-1t1cqjo.jpeg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=976&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Dr. Peggy Lemaux, holding seeds from the hypoallergenic wheat she helped develop with genetic engineering.</span>
<span class="attribution"><span class="source">James Block</span>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>For example, my adviser at UC Berkeley developed, with colleagues, a <a href="https://www.foodbusinessnews.net/articles/10892-bioengineering-of-wheat-still-faces-significant-challenges">hypoallergenic variety of wheat</a>. Seeds for this wheat are held captive in envelopes in the basement of our building, untouched for years. A <a href="https://geneticliteracyproject.org/2017/10/11/green-technology-disease-resistant-gmo-tomato-eliminate-need-copper-pesticides-double-yields-blocked-public-fears/">tomato</a> that uses a sweet pepper gene to defend against a bacterial disease, eliminating the need for copper-based pesticide application, has struggled to secure funding to move forward. <a href="https://doi.org/10.1073/pnas.0709005105">Carrot</a>, <a href="https://doi.org/10.1007/s11103-004-3415-9">cassava</a>, <a href="https://doi.org/10.1007/s11248-009-9256-1">lettuce</a>, <a href="https://doi.org/10.1093/jxb/erm299">potato</a> and <a href="https://doi.org/10.1038/nbt1010-1012">more</a> have been engineered for increased nutritional value. These varieties demonstrate the creativity and expertise of researchers in bringing beneficial new traits to life. Why, then, can’t I buy bread made with hypoallergenic wheat at the grocery store?</p>
<h2>Loosening the grip of Big Agriculture</h2>
<p>Research and development of a new genetically engineered crop <a href="https://croplife-r9qnrxt3qxgjra4.netdna-ssl.com/wp-content/uploads/2014/04/Getting-a-Biotech-Crop-to-Market-Phillips-McDougall-Study.pdf">costs</a> around US$100 million at large seed companies. Clearing the regulatory hurdles laid out by the U.S. Department of Agriculture, EPA and/or FDA (depending on the engineered trait) takes between five and seven years and an additional $35 million. Regulation is important and genetically engineered products should be carefully evaluated. But, the expense allows only large corporations with extensive capital to compete in this arena. The price shuts small companies, academic researchers and NGOs out of the equation. To recoup their $135 million investment in crop commercialization, companies develop products to satisfy the biggest markets of seed buyers – growers of corn, soybean, sugar beet and cotton.</p>
<p>The costs of research and development are far lower with CRISPR due to its precision and predictability. And early indications suggest that using CRISPR for mutation will not be subject to the same regulatory hurdles and costs in the U.S. A <a href="https://www.usda.gov/media/press-releases/2018/03/28/secretary-perdue-issues-usda-statement-plant-breeding-innovation">press release</a> on March 28, 2018 by the U.S. Department of Agriculture says that “under its biotechnology regulations, USDA does not regulate or have any plans to regulate plants that could otherwise have been developed through traditional breeding techniques” if they are developed with approved laboratory procedures. </p>
<p>If the EPA and FDA follow suit with reasonable, less costly regulations, CRISPR may escape the dominant financial grasp of large seed companies. Academics, small companies and NGO researchers may see hard work and intellectual capital yield beneficial genome-edited products that are not forever relegated to the basements of research buildings.</p>
<h2>Common ground: CRISPR for sustainability</h2>
<p>In the six years since the genome editing capabilities of CRISPR were unlocked, academics, startups and established corporations have announced new agricultural products in the pipeline that use this technology. Some of these focus on traits for consumer health, such as <a href="https://doi.org/10.1111/pbi.12837">low-gluten</a> or gluten-free wheat for people with celiac disease. Others, such as non-browning <a href="https://doi.org/10.1038/nature.2016.19754">mushrooms</a>, can decrease food waste. </p>
<p>The lingering California drought demonstrated the importance of crop varieties that use water efficiently. <a href="https://doi.org/10.1111/pbi.12603">Corn</a> with greater yield under drought stress has already been made using CRISPR, and it is only a matter of time before CRISPR is used to increase drought tolerance in other crops. Powdery mildew-resistant <a href="https://doi.org/10.1038/s41598-017-00578-x">tomatoes</a> could save billions of dollars and eliminate spraying of fungicides. A <a href="https://doi.org/10.1038/ng.3733">tomato</a> plant that flowers and makes fruit early could be used in northern latitudes with long days and shorter growing seasons, which will become more important as climate changes. </p>
<h2>The rules are made, but is the decision final?</h2>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/233144/original/file-20180822-149496-1g0k9zx.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/233144/original/file-20180822-149496-1g0k9zx.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=437&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/233144/original/file-20180822-149496-1g0k9zx.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=437&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/233144/original/file-20180822-149496-1g0k9zx.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=437&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/233144/original/file-20180822-149496-1g0k9zx.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=549&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/233144/original/file-20180822-149496-1g0k9zx.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=549&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/233144/original/file-20180822-149496-1g0k9zx.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=549&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Dave Chapman, owner of Long Wind Farm, checks for insects on organic tomato plant leaves in his greenhouse in Thetford, Vt. Chapman is a leader of a farmer-driven effort to create an additional organic label that would exclude hydroponic farming and concentrated animal feeding operations.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Food-and-Farm-Organic-Label/58acc6a056af49e08756acdc004aaa24/7/0">Lisa Rathke/AP Photo</a></span>
</figcaption>
</figure>
<p>In <a href="https://www.ams.usda.gov/rules-regulations/organic/nosb/recommendations/fall2016">2016</a> and <a href="https://www.ams.usda.gov/rules-regulations/organic/nosb/recommendations/fall2017">2017</a>, the U.S. <a href="https://www.ams.usda.gov/rules-regulations/organic/nosb">National Organic Standards Board</a> (NOSB) voted to exclude all genome-edited crops from organic certification. </p>
<p>But in my view, they should reconsider. </p>
<p>Some organic growers I interviewed agree. “I see circumstances under which it could be useful for short-cutting a process that for traditional breeding might take many plant generations,” says Tom Willey, an organic farmer emeritus from California. The disruption of natural ecosystems is a major challenge to agriculture, Willey told me, and while the problem cannot be wholly addressed by genome editing, it could lend an opportunity to “reach back into genomes of the wild ancestors of crop species to recapture genetic material” that has been lost through millennia of breeding for high yields.</p>
<p>Breeders have successfully used traditional breeding to reintroduce such diversity, but “in the light of the urgency posed by climate change, we might wisely employ CRISPR to accelerate such work,” Willey concludes. </p>
<p>Bill Tracy, an organic corn breeder and professor at the University of Wisconsin–Madison, says, “Many CRISPR-induced changes that could happen in nature could have benefits to all kinds of farmers.” But, the NOSB has already voted on the issue and the rules are unlikely to change without significant pressure. “It’s a question of what social activity could move the needle on that,” Tracy concludes. </p>
<p>People on all sides of biotechnology debates want to maximize human and environmental outcomes. Collaborative problem-solving by organic (and conventional) growers, specialists in sustainable agriculture, biotechnologists and policymakers will yield greater progress than individual groups acting alone and dismissing each other. The barriers to this may seem large, but they are of our own making. Hopefully, more people will gain the courage to plug the projector back in and let the conversation continue.</p><img src="https://counter.theconversation.com/content/101585/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The funding for Rebecca Mackelprang&#39;s postdoctoral position comes from the Winkler Family Foundation.</span></em></p>Is gene editing compatible with organic farming? A scholar explains the differences between old genetic engineering and CRISPR methods, and why the latter is similar to tradition plant breeding.Rebecca Mackelprang, Postdoctoral Scholar, University of California, BerkeleyLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1041052018-10-09T10:44:53Z2018-10-09T10:44:53ZMeet the trillions of viruses that make up your virome<figure><img src="https://images.theconversation.com/files/238796/original/file-20181001-195278-zxp1fb.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Every surface of our body -- inside and out -- is covered in microorganisms: bacteria, viruses, fungi and many other microscopic life forms.</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/microbiome-microorganisms-bacteria-viruses-microbes-crawling-714045286?src=4HMvDP6bwGcrS9t-IJGgSA-1-6">vrx/Shutterstock.com</a></span></figcaption></figure><p><a href="https://theconversation.com/conozca-los-billones-de-virus-que-constituyen-su-viroma-104813"><em>Leer en español</em></a>.</p>
<p>If you think you don’t have viruses, think again.</p>
<p>It may be hard to fathom, but the human body is occupied by large collections of microorganisms, commonly referred to as our microbiome, that have evolved with us since the early days of man. Scientists have only recently begun to quantify the microbiome, and discovered it is inhabited by at least <a href="http://doi.org/10.1371/journal.pbio.1002533">38 trillion bacteria</a>. More intriguing, perhaps, is that bacteria are not the most abundant microbes that live in and on our bodies. That award goes to viruses.</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/238779/original/file-20181001-195256-6s5ayh.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/238779/original/file-20181001-195256-6s5ayh.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/238779/original/file-20181001-195256-6s5ayh.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=703&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/238779/original/file-20181001-195256-6s5ayh.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=703&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/238779/original/file-20181001-195256-6s5ayh.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=703&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/238779/original/file-20181001-195256-6s5ayh.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=883&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/238779/original/file-20181001-195256-6s5ayh.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=883&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/238779/original/file-20181001-195256-6s5ayh.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=883&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Transmission electron micrograph of multiple bacteriophages attached to a bacterial cell wall.</span>
<span class="attribution"><a class="source" href="https://upload.wikimedia.org/wikipedia/commons/5/52/Phage.jpg">Dr. Graham Beards</a>, <a class="license" href="http://creativecommons.org/licenses/by-sa/4.0/">CC BY-SA</a></span>
</figcaption>
</figure>
<p>It has been estimated that there are over <a href="http://doi.org/10.1016/j.coviro.2011.12.004">380 trillion viruses</a> inhabiting us, a community collectively known as the human virome. But these viruses are not the dangerous ones you commonly hear about, like those that cause the flu or the common cold, or more sinister infections like Ebola or dengue. Many of these viruses infect the bacteria that live inside you and are known as bacteriophages, or phages for short. The human body is a breeding ground for phages, and despite their abundance, we have very little insight into what all they or any of the other viruses in the body are doing. </p>
<p>I am a physician-scientist studying the human microbiome by focusing on viruses, because I believe that harnessing the power of bacteria’s ultimate natural predators will teach us how to prevent and combat bacterial infections. One might rightly assume that if viruses are the most abundant microbes in the body, they would be the target of the majority of human microbiome studies. But that assumption would be horribly wrong. The study of the human virome lags so far behind the study of bacteria that we are only just now uncovering some of their most basic features. This lag is due to it having taken scientists much longer to recognize the presence of a human virome, and a lack of standardized and sophisticated tools to decipher what’s actually in your virome.</p>
<h2>The 411 on the virome</h2>
<p>Here’s a few of the things we have learned thus far. Bacteria in the human body are not in love with their many phages that live in and around them. In fact they developed CRISPR-Cas systems – which <a href="http://doi.org/10.1016/j.cell.2014.05.010">humans have now co-opted for editing genes</a> – to rid themselves of phages or to <a href="http://doi.org/10.1126/science.1138140">prevent phage infections altogether</a>. Why? Because phages kill bacteria. They take over the bacteria’s machinery and force them to make more phages rather than make more bacteria. When they are done, they burst out of the bacterium, destroying it. Finally, phages sit on our body surfaces <a href="http://doi.org/10.1073/pnas.1305923110">just waiting to cross paths with vulnerable bacteria</a>. They are basically bacteria stalkers. </p>
<figure class="align-left zoomable">
<a href="https://images.theconversation.com/files/238782/original/file-20181001-195256-8oif9s.png?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/238782/original/file-20181001-195256-8oif9s.png?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/238782/original/file-20181001-195256-8oif9s.png?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=744&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/238782/original/file-20181001-195256-8oif9s.png?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=744&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/238782/original/file-20181001-195256-8oif9s.png?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=744&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/238782/original/file-20181001-195256-8oif9s.png?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=934&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/238782/original/file-20181001-195256-8oif9s.png?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=934&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/238782/original/file-20181001-195256-8oif9s.png?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=934&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">A virus called a bacteriophage infects bacteria and inserts its genetic material into the cell. The bacterium ‘reads’ the genetic instructions and manufactures more viruses which destroy the bacterium when they exit the cell.</span>
<span class="attribution"><a class="source" href="https://upload.wikimedia.org/wikipedia/commons/b/ba/11_Hegasy_Phage_T4_Wiki_E_CCBYSA.png">Guido4</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>It’s clear that there’s a war being fought on our body surfaces every minute of every day, and we haven’t a clue who’s winning or what the consequences of this war might be. </p>
<p>Viruses may inhabit all surfaces both inside and outside of the body. Everywhere researchers have looked in the human body, viruses have been found. Viruses in the blood? Check. Viruses on the skin? Check. Viruses in the lungs? Check. Viruses in the urine? Check. And so on. To put it simply, when it comes to where viruses live in the human body, figuring out where they don’t live is a far better question than <a href="http://doi.org/10.1016/j.jmb.2014.07.002">asking where they do</a>. </p>
<p>Viruses are contagious. But we often don’t think about bacterial viruses as being easily shared. Researchers have shown that <a href="http://doi.org/10.1186/s40168-016-0212-z">just living with someone will lead to rapid sharing of the viruses in your body</a>. If we don’t know what the consequences are of the constant battle between bacteria and viruses in our body, then it gets exponentially more complicated considering the battle between your bacteria and their viruses that are then shared with everyone including your spouse, your roommate, and even your dog. </p>
<h2>Viruses keeping us healthy?</h2>
<figure class="align-center zoomable">
<a href="https://images.theconversation.com/files/238804/original/file-20181001-195260-1d8xn0z.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/238804/original/file-20181001-195260-1d8xn0z.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/238804/original/file-20181001-195260-1d8xn0z.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=399&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/238804/original/file-20181001-195260-1d8xn0z.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=399&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/238804/original/file-20181001-195260-1d8xn0z.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=399&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/238804/original/file-20181001-195260-1d8xn0z.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=502&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/238804/original/file-20181001-195260-1d8xn0z.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=502&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/238804/original/file-20181001-195260-1d8xn0z.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=502&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption">Viruses destroy the bacterium when they burst out of the cell. Here, the clear circles reveal where the bacteriophage have killed the bacteria.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/bacteriophage-activity-little-spots-on-right-175492538?src=ScqQu3941Q4d-DJ6NHxD6g-1-81">Guido4/Shutterstock.com</a></span>
</figcaption>
</figure>
<p>Ultimately, we need to know what all these viruses in the human body are doing, and figure out whether we can take advantage of our virome to promote our health. But it’s probably not clear at this point why anyone would believe that our virome may be helpful. </p>
<p>It may seem counterintuitive, <a href="http://doi.org/10.1136/bmj.j831">but harming our bacteria can be harmful to our health</a>. For example, when our healthy bacterial communities are disturbed by antibiotic use, other microbial bad guys, also called pathogens, take advantage of the opportunity to invade our body and make us sick. Thus, in a number of human conditions, our healthy bacteria play important roles in preventing pathogen intrusion. Here’s where viruses come in. They’ve already figured out how to kill bacteria. It’s all they live for. </p>
<p>So the race is on to find those viruses in our viromes that have already figured out how to protect us from the bad guys, while leaving the good bacteria intact. Indeed, there are recent anecdotal examples <a href="http://doi.org/10.1128/AAC.00954-17">utilizing phages successfully to treat life-threatening infections</a> from bacteria resistant to most if not all available antibiotics – a treatment known as phage therapy. Unfortunately, these treatments are and will continue to be hampered by inadequate information on how phages behave in the human body and the unforeseen consequences their introduction may have on the human host. Thus, phage therapy remains heavily regulated. At the current pace of research, it may be many years before phages are used routinely as anti-infective treatments. But make no mistake about it; the viruses that have evolved with us for so many years are not only part of our past, but will play a significant role in the future of human health.</p><img src="https://counter.theconversation.com/content/104105/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Just because you don't have the flu doesn't mean that your aren't teeming with viruses inside and out. But what are all these viruses doing, if they aren't making you sick?David Pride, Associate Director of Microbiology, University of California San DiegoChandrabali Ghose, Visiting Scientist, The Rockefeller UniversityLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1003552018-09-24T12:36:30Z2018-09-24T12:36:30ZShould we edit the genomes of human embryos? A geneticist and social scientist discuss<figure><img src="https://images.theconversation.com/files/235664/original/file-20180910-123110-1sjjjpb.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/group-multiethnic-babies-crawling-isolated-on-144900358?src=1eUR-dDDVFwjE22c02M5GA-1-22">Sirtravelalot/Shutterstock.com</a></span></figcaption></figure><p><em>This is an article from <a href="https://theconversation.com/uk/topics/head-to-head-62019">Head to Head</a>, a series in which academics from different disciplines chew over current debates. Let us know what else you’d like covered – all questions welcome. Details of how to contact us are at the end of the article.</em></p>
<p><strong>Felicity Boardman</strong>: The birth of a child with genetic disease is generally an unexpected event. The parents of these children typically won’t have a family history with the condition, or even be aware that they are genetic “carriers”: that they can transmit a genetic condition to their offspring, but do not have it themselves. Indeed, there are currently only two carrier screening programmes active in the UK that are implemented during pregnancy (one for for thalassaemia, and the other for sickle cell trait). So for most parents, discovering the condition in their family occurs through their child’s diagnosis, either through the <a href="https://www.nhs.uk/conditions/pregnancy-and-baby/newborn-blood-spot-test/">newborn heel prick test</a>, or following the onset of symptoms. </p>
<p>Even in cases where a genetic condition in the foetus is identified during pregnancy, the options for would-be parents remain extremely limited. Many of the most common genetic conditions still lack effective treatments or cures. This means that, for many parents, the information leads to a decision about whether or not to terminate the pregnancy, or continue in the knowledge that the child will have the condition.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/237127/original/file-20180919-158213-1pdwaq9.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/237127/original/file-20180919-158213-1pdwaq9.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=390&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/237127/original/file-20180919-158213-1pdwaq9.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=390&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/237127/original/file-20180919-158213-1pdwaq9.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=390&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/237127/original/file-20180919-158213-1pdwaq9.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=490&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/237127/original/file-20180919-158213-1pdwaq9.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=490&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/237127/original/file-20180919-158213-1pdwaq9.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=490&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Sickled red blood cells in liver tissue.</span>
<span class="attribution"><a class="source" href="https://wellcomecollection.org/works/x3e4ekce?query=Sickle+cell+disease">SB Lucas/Wellcome Collection</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p>The introduction of <a href="https://theconversation.com/scientists-edit-human-embryos-to-safely-remove-disease-for-the-first-time-heres-how-they-did-it-81925">genome editing</a>, however, signals a dramatic departure from this usual pathway through reproductive care. Although the foundations of genome editing were laid initially in the 1960s when proteins were first used to “cut” DNA, the recent development of new techniques and technologies (such as <a href="https://theconversation.com/uk/topics/crispr-15704">CRISPR-Cas9</a>) has made genome editing more precise, more cost-effective and consequently more accessible than ever before. </p>
<p>By intervening before a child is even born, the use of genome editing in human reproduction has the potential to alleviate some of the complicated and painful decisions around pregnancy termination – by providing a reproductive option that has, up until now, not been possible. That is, the possibility of removing the disease-causing genetic variant, while simultaneously preserving the life of the foetus. </p>
<p><strong>Helen O’Neill</strong>: Genome editing indeed marks a significant shift, and not only in the area of reproduction, but also in the direction of tailored treatments and personalised medicine. It offers hope to those who, before now, have not had any better options than prescriptions and palliative care.</p>
<p>It’s an incredibly exciting time for such research both in terms of discovery and diagnostics. The advent of CRISPR genome editing has catapulted previous efforts in genomics and is being adopted globally. My research, for example, uses CRISPR genome editing to assess the treatment and understanding of sex chromosome disorders and neuromuscular disorders. There are <a href="https://theconversation.com/why-treat-gene-editing-differently-in-two-types-of-human-cells-51843">two ways</a> in which genome editing could be used for both treatment and prevention: somatic cell therapy, which could be used in newborns and adults, and germline genome editing, which would be used in an early embryo to prevent a disorder. In this second type, genome editing would aim to alter every cell of a resulting baby, and therefore these changes would be passed on to future generations, meaning that disease causing variants would be prevented from being passed on.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/237120/original/file-20180919-158213-7115hv.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/237120/original/file-20180919-158213-7115hv.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=338&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/237120/original/file-20180919-158213-7115hv.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=338&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/237120/original/file-20180919-158213-7115hv.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=338&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/237120/original/file-20180919-158213-7115hv.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=424&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/237120/original/file-20180919-158213-7115hv.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=424&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/237120/original/file-20180919-158213-7115hv.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=424&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">CRISPR-Cas9 allows scientists to target and activate or silence specific genes.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/dna-molecule-structure-strand-repair-editing-774492757?src=fsLzr20sTEzmuh_eWpHdWg-1-10">Vrx/Shutterstock.com</a></span>
</figcaption>
</figure>
<p>The use of genetic technologies in reproduction is <a href="https://www.theguardian.com/commentisfree/2017/aug/04/editing-human-genome-consumer-eugenics-designer-babies">frequently criticised</a> for harbouring <a href="https://theconversation.com/three-person-ivf-has-nothing-to-do-with-eugenics-but-its-time-for-a-designer-baby-debate-23996">eugenic undertones</a>. But genetic selection occurs with or without these technologies. For example, we make decisions about the genetics of our future offspring when we choose our mate. We make decisions about the health of our future offspring when we take supplements such as <a href="https://theconversation.com/folic-acid-in-pregnancy-mthfr-gene-explains-why-the-benefits-may-differ-95302">folic acid</a> and improve our diet during pregnancy. Decades of research have yielded <a href="https://theconversation.com/complex-guidelines-on-eating-fish-when-pregnant-mean-that-mothers-and-babies-are-missing-out-83587">ever-increasing information</a> about how we can protect and nurture our embryos, not only by including essential macronutrients but also by excluding harmful exposures such as alcohol and tobacco. We don’t ignore these welfare warnings. Nor is it considered elitist to adhere to them by choice to deliver a healthy baby.</p>
<p>But when comparing these genetic prompts to more purposeful permutations of our genetics using gene editing technology, the rationalisation for wanting a healthy baby somehow becomes displaced with irrational ideas about the creation of a “perfect” baby.</p>
<p>It is true that advances in research rarely lend themselves so quickly to clinical adoption. But safety is obviously the number one prerequisite for any research development to become medical practice. Proceeding with such medical advances will always be subject to rigorous oversight. So <a href="https://www.newscientist.com/article/2179920-revealed-what-the-uk-public-really-thinks-about-the-future-of-science/">for many</a>, genome editing – and the era of <a href="https://theconversation.com/personalised-medicine-has-obvious-benefits-but-has-anyone-thought-about-the-issues-59158">personalised medicine</a> – is not something to be feared but embraced.</p>
<h2>Mistrust and myth</h2>
<p><strong>FB</strong>: While caution is a good thing, fear of the technologies can make meaningful and progressive debate quite difficult. The association of genome editing with “<a href="https://theconversation.com/why-the-case-against-designer-babies-falls-apart-45256">designer babies</a>”, for example, although making for catchy headlines, masks the intended uses of the technologies. The connotations of frivolity, commercialism and superficial decision making that comes with the term “designer” does a great disservice to the parents in these difficult situations who are facing complex and often deeply painful decisions.</p>
<p><strong>HON</strong>: Yes: the term “designer” suggests that there is an element of choice and privilege to a baby that may be born with an edited genome. In fact, the opposite is more likely to be true; people will not edit the genomes of their embryos out of choice, but because they have no choice if they are to deliver a healthy, viable baby.</p>
<p>And as it stands, <a href="https://www.nature.com/articles/d41586-018-05462-w">we are still debating</a> the number of genes in the human genome and certainly do not know what all of the genes do. Even if we did, the unpredictability in the mechanism of genetic crossover between parental genomes precludes any realistic control or prediction of the majority of traits. Choosing partners based on what we see on the outside is a far more reliable method for designing our babies’ appearance.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/237728/original/file-20180924-85785-1y6nasc.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/237728/original/file-20180924-85785-1y6nasc.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=373&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/237728/original/file-20180924-85785-1y6nasc.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=373&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/237728/original/file-20180924-85785-1y6nasc.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=373&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/237728/original/file-20180924-85785-1y6nasc.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=469&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/237728/original/file-20180924-85785-1y6nasc.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=469&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/237728/original/file-20180924-85785-1y6nasc.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=469&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">All babies are ‘designed’ to some extent when we choose a partner.</span>
<span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/parents-their-newborn-baby-boy-on-729856267?src=XHAK_BLe7vsMGnO_t72a9w-1-0">Jacob Lund/Shutterstock.com</a></span>
</figcaption>
</figure>
<p>There is no doubt that a subject like this needs widespread discussion and debate and in fact <a href="https://www.newscientist.com/article/2179920-revealed-what-the-uk-public-really-thinks-about-the-future-of-science/">recent surveys</a> show that the public are optimistic about genome editing for curing diseases, but there can also be a lack of trust about the intended use of this technology. The distraction from the good that this technology can do is frustrating as a researcher. We should not extrapolate the worst possible outcome which encourages unrealistic and disingenuous ideas focusing on dystopian scenarios.</p>
<p><strong>FB</strong>: I think some of this mistrust stems from fear of the unknown and a concern that this technology stands to alter not only our biology, but also our society. People with genetic disabilities, for example, those with spinal muscular atrophy, haemophilia and <a href="https://theconversation.com/discovering-the-ancient-origin-of-cystic-fibrosis-the-most-common-genetic-disease-in-caucasians-100499">cystic fibrosis</a> (who I work with during my research), are set to be impacted by the consequences of genome editing, yet they are not always included in stakeholder debates as much as they could be. This is in spite of the fact that people with disabilities have much to contribute to our understanding of what life with genetic disease is really like. Insights that are highly relevant to decisions about which conditions are suitable candidates for genome editing.</p>
<p><strong>HON</strong>: But the use of genome editing can also be seen as addressing some of the objections to prenatal testing and pregnancy termination raised by disability rights supporters. By treating the foetus’ or embyro’s condition, rather than terminating them, genome editing may be an attractive alternative for those who disagree with pregnancy termination or embryo disposal on the grounds of disability or otherwise. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/237114/original/file-20180919-158219-1ogp1mi.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/237114/original/file-20180919-158219-1ogp1mi.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=661&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/237114/original/file-20180919-158219-1ogp1mi.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=661&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/237114/original/file-20180919-158219-1ogp1mi.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=661&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/237114/original/file-20180919-158219-1ogp1mi.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=830&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/237114/original/file-20180919-158219-1ogp1mi.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=830&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/237114/original/file-20180919-158219-1ogp1mi.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=830&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Separation of DNA fragments.</span>
<span class="attribution"><a class="source" href="https://wellcomecollection.org/works/gkhb2nrc?page=3&amp;query=DNA">Guy Tear/Wellcome Collection</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<h2>What’s at stake?</h2>
<p><strong>FB</strong>: That’s of course true, but for some, this development is regarded as coming at a cost. Genome editing not only changes the genome of the embryo it treats, but also that of every generation that comes after it, and so critical questions still remain about how and when it would be ethically and socially appropriate to implement it. Indeed, it <a href="http://nuffieldbioethics.org/project/genome-editing-human-reproduction">has been suggested</a> that over time, genome editing could effectively remove particular disease-causing traits from the human gene pool.</p>
<p>While this may seem a positive development to many people, the question of which conditions and traits genome editing should be used to treat, and which it should not, is far from straightforward. <a href="https://www.ncbi.nlm.nih.gov/pubmed/30196552">Research I have conducted</a> with families living with a range of conditions that could all one day be candidate conditions for genome editing, for example, has revealed that a person’s relationship to their genetic condition is often complex. For some, their disability is an integral and valued part of their identity, while for others, an unwelcome burden. As such, ascertaining the quality of life of a person with a genetic disorder (particularly before birth) is a near impossible task.</p>
<p>As genome editing technologies move into mainstream healthcare and become widely adopted, it is possible that would-be parents will feel under pressure to use them. This is a concern that has long been raised in relation to informed consent and antenatal screening <a href="https://www.ncbi.nlm.nih.gov/pubmed/20947230">for Down’s Syndrome</a>. The potential stigmatisation and branding of parents who forgo the technologies as “selfish” or “irresponsible” needs to be seriously considered, as well as the possibility that this stigma could extend to the disabled people already living with “editable” conditions (the numbers of whom are likely to reduce over time).</p>
<p>Indeed, the public profile of these (often rare) genetic conditions will shift and alter through the use of genome editing – from conditions once considered “chance” occurrences, to preventable diseases. This change is likely to have social consequences, as well as biological ones.</p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/237284/original/file-20180920-129877-1b14sjq.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/237284/original/file-20180920-129877-1b14sjq.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=375&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/237284/original/file-20180920-129877-1b14sjq.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=375&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/237284/original/file-20180920-129877-1b14sjq.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=375&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/237284/original/file-20180920-129877-1b14sjq.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=472&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/237284/original/file-20180920-129877-1b14sjq.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=472&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/237284/original/file-20180920-129877-1b14sjq.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=472&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">Fibrous deposits in pancreas due to cystic fibrosis.</span>
<span class="attribution"><a class="source" href="https://wellcomecollection.org/works/sbbr52xk?query=cystic+fibrosis">Anne Clark, University of Oxford/Wellcome Collection</a>, <a class="license" href="http://creativecommons.org/licenses/by/4.0/">CC BY</a></span>
</figcaption>
</figure>
<p><strong>HON</strong>: It is essential to put genome editing in context with what is already available in terms of screening and pre-implantation genetic diagnosis – which has been available for 30 years. With this, every single condition needs to be appraised and legally approved before it can be tested for. And ultimately, the decision comes from the parents.</p>
<p>It is also important to remember that we cannot predict the pattern of genetics or the heritability of disorders. So suggesting that conditions would be “eliminated” is certainly not the goal of researchers, nor is it realistic. Not all genetic disorders are inherited from the family line, many are sporadic or “<a href="https://www.cancer.gov/publications/dictionaries/genetics-dictionary/def/de-novo-mutation"><em>de novo</em></a>” mutations which occur through chance. While germline genome editing certainly has consequences for future generations, many current standard treatments are not ideal and have unwanted side effects, but they are the best we currently have. Take for example cancer radiation therapy, which not only alters, but destroys, the germline.</p>
<p>More research is critical. We know less about the early developmental stages of a human embryo than we do of mice, worms, flies and fish. Knowledge is the most powerful prescription you can give, but it comes with a burden. It is important that with each new discovery we are able to fully consolidate our knowledge before advancing to the next level in research.</p>
<p><strong>FB</strong>: I agree – and also think it’s important to note that we need more research that explores the technologies from a range of vantage points. Currently, there is a lack of dialogue between the various disciplines working in this area, including geneticists, scientists, bioethicists, sociologists and disability studies scholars. By removing some of the disciplinary divisions, we may better be able to see the full consequences of the technologies for everyone whose lives will be affected by them, the list of which seems to be ever-expanding.</p>
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<p class="fine-print"><em><span>The authors do not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Academics from different disciplines come Head to Head in this series to tackle topical debates.Felicity Boardman, Assistant Professor in Social Science and Systems in Health, University of WarwickHelen O'Neill, Lecturer in Reproductive and Molecular Genetics, UCLLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1030872018-09-12T17:03:49Z2018-09-12T17:03:49ZGene-editing technique CRISPR identifies dangerous breast cancer mutations<figure><img src="https://images.theconversation.com/files/235935/original/file-20180912-181248-1b284hk.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">Breast cancer type 1 (BRCA1) is a human tumor suppressor gene, found in all humans. Its protein, also called by the synonym BRCA1, is responsible for repairing DNA. </span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-illustration/brca1-3d-structure-human-tumor-suppressor-564987043?src=9vuGmVWb0R09Kyz8mhe8EQ-1-13">ibreakstock/Shutterstock.com</a></span></figcaption></figure><p>More than 1 million women have had genetic testing of BRCA1 and BRCA2, genes in which mutations can dramatically increase the risk for early onset breast and ovarian cancer. But for many women the test results have been ambiguous. That’s because it’s not clear where certain genetic variations are harmless or cause cancer. </p>
<p>BRCA1 was amongst the first cancer predisposition genes discovered, and it has been studied for over 20 years. The gene produces a protein that repairs DNA damage, which might otherwise lead to the formation of tumors. Since its discovery, researchers and clinicians have identified many genetic variations in BRCA1, but for most of these, we are unable to tell whether they impair function of the gene – raising the risk of cancer – or whether they are perfectly harmless. </p>
<p><a href="http://krishna.gs.washington.edu/index.html">Our research team</a> works in the emerging field of genomic medicine, which uses an individual’s genetic information to prescribe care. We recognized that such “variants of uncertain significance” limited the utility of genetic testing and the prospects for genomic medicine. We know that problem is likely to get worse, as the number of uncertain variants in BRCA1 and other “medically actionable” genes is expected to grow exponentially as genetic testing is expanded to entire populations.</p>
<p><a href="https://www.nature.com/articles/s41586-018-0461-z">In a study</a>, we set out to apply CRISPR genome editing to solve the challenge posed by these variants of uncertain significance. CRISPR has tremendous potential because the technology allows researchers like us to tinker with human genes. CRISPR allows us to make very specific changes, “edits” to our DNA – thus the phrase, “genome editing.” </p>
<p>Although there are many studies that are attempting to use CRISPR to treat disease, it can also be used to introduce specific mutations into human cells that grow in a dish, for the purposes of studying what effects these mutations have on the cell – for instance, whether or not they cause a gene to malfunction.</p>
<p><a href="https://www.nature.com/articles/s41586-018-0461-z">In our study</a>, we used CRISPR genome editing to deliberately engineer some 4,000 different variants of the BRCA1 gene in human cells, nearly all possible variants in the most important regions of this gene. Importantly, the survival of the human cells that we used is dependent on intact function of the BRCA1 gene. As a consequence, the cells containing mutations that disrupted the function of the BRCA1 gene were unable to survive. On the other hand, the cell containing mutations that had no effect on the function of the BRCA1 gene were just fine. Using DNA sequencing, we tracked which mutations were associated with cell death versus cell survival. </p>
<p>When we compared the mutations that caused cell death to variants that are known to increase cancer risk, we noticed that they were the same. This gave us the confidence to say that the behavior of these variants in the cells in the dish was predictive of cancer risk in humans. </p>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/236035/original/file-20180912-133895-1rju0xs.png?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/236035/original/file-20180912-133895-1rju0xs.png?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=377&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/236035/original/file-20180912-133895-1rju0xs.png?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=377&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/236035/original/file-20180912-133895-1rju0xs.png?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=377&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/236035/original/file-20180912-133895-1rju0xs.png?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=474&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/236035/original/file-20180912-133895-1rju0xs.png?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=474&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/236035/original/file-20180912-133895-1rju0xs.png?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=474&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">The research team first grew human cells in culture. We then used the gene-editing tool CRISPR to create variations in particular regions of the BRCA1 gene. We grew these edited cells for 11 days and then determined which variants had no effect; which ones damaged the BRCA1 protein, making it nonfunctional and resulting in the cells dying; and which ones were intermediate – only moderately impacting cell survival. When we compared these results with clinical data, our laboratory-based measurements matched the effects of the mutations in the patients.</span>
<span class="attribution"><span class="source">Findlay, et al., Nature.</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
</figcaption>
</figure>
<p>Although scientists have used laboratory assays to test variants in BRCA1 for many years, our work is different for three reasons. </p>
<p>First, we tested many more variants than have ever been tested, including thousands that have never been observed before but almost certainly exist in at least hundreds of living humans. </p>
<p>Second, historically BRCA1 variants have been tested in genes taken “out of context” – specifically, studying only the DNA sequences that encode the BRCA1 protein, rather than the surrounding sequences that regulate how it is expressed. CRISPR allows us, for the first time, to create and test the mutations in the human genome itself. </p>
<p>Finally, for the hundreds of BRCA1 variants seen in patients where we do have a good sense of whether or not they increase risk of breast and ovarian cancer, our predictions based on our CRISPR studies are nearly perfectly accurate. That is, the variants compatible with cell survival in our assay are benign in patients, while the variants that impair cell survival in our assay cause cancer risk. This gives us confidence in our predictions for other variants that have never before been observed but inevitably will be, particularly as more and more women are screened for mutations in this gene.</p>
<p>Because of this strong agreement with “gold standard” data derived from human studies, we predict our results can be used to provide better answers to women with challenging-to-interpret variants in BRCA1. This includes many women that have an elevated risk of cancer, but would previously have been missed by genetic testing. To these women, this knowledge of what their mutations mean may critically inform the medical care that they receive.</p><img src="https://counter.theconversation.com/content/103087/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jay Shendure receives funding from Brotman Baty Institute for Precision Medicine, National Institutes of Health, Allen Frontiers Foundation, Howard Hughes Medical Group. The authors are co-inventors on a patent application related to the saturation genome editing method, and the scores described here require a license from the University of Washington for for-profit or commercial use. </span></em></p><p class="fine-print"><em><span>Lea Starita is employed by the Brotman Baty Institute for Precision Medicine. </span></em></p><p class="fine-print"><em><span>Greg Findlay does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.</span></em></p>Mutations in BRCA genes are linked to the early onset of breast and ovarian cancers. But the effect of most mutations is unclear. Now new research can distinguish harmless from dangerous mutations.Jay Shendure, Professor of Genome Sciences, University of WashingtonGreg Findlay, M.D.-Ph.D. Student in Genome Sciences, University of WashingtonLea Starita, Research Assistant Professor of Genome Sciences, University of WashingtonLicensed as Creative Commons – attribution, no derivatives.tag:theconversation.com,2011:article/1007192018-08-20T10:30:22Z2018-08-20T10:30:22ZGenetically modified mosquitoes may be best weapon for curbing disease transmission<figure><img src="https://images.theconversation.com/files/231765/original/file-20180813-2912-10016ka.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=496&amp;fit=clip" /><figcaption><span class="caption">More than 3.9 billion people live in regions where the Aedes aegypti mosquito is present. This species transmits Zika, dengue, chikungunya, and yellow fever.
</span> <span class="attribution"><a class="source" href="https://www.shutterstock.com/image-photo/mosquito-on-human-skin-sunset-200494427?src=hPItT4Sw3Cn291eDH36Amw-1-5">mycteria/Shutterstock.com</a></span></figcaption></figure><p>Mosquitoes are some of the most deadly creatures on the planet. They carry viruses, bacteria and parasites, which they transmit through bites, infecting some <a href="https://www.ebmedicine.net/topics.php?paction=showTopic&amp;topic_id=405">700 million people and killing more than 1 million each year</a>. </p>
<p>With international travel, migration and climate change, these infections are no longer confined to tropical and subtropical developing countries. Pathogens such as West Nile virus and Zika virus have caused significant outbreaks in the United States and its territories that are likely to continue, with new invasive pathogens being discovered all the time. Currently, control of these diseases is mostly limited to broad-spectrum insecticide sprays, <a href="https://extension.psu.edu/potential-health-effects-of-pesticides">which can harm both humans and non-target animals and insects</a>. What if there was a way to control these devastating diseases without the environmental problems of widespread insecticide use?</p>
<figure class="align-right zoomable">
<a href="https://images.theconversation.com/files/231774/original/file-20180813-2915-1owb6a2.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=1000&amp;fit=clip"><img alt="" src="https://images.theconversation.com/files/231774/original/file-20180813-2915-1owb6a2.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=237&amp;fit=clip" srcset="https://images.theconversation.com/files/231774/original/file-20180813-2915-1owb6a2.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=405&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/231774/original/file-20180813-2915-1owb6a2.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=405&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/231774/original/file-20180813-2915-1owb6a2.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=405&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/231774/original/file-20180813-2915-1owb6a2.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=509&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/231774/original/file-20180813-2915-1owb6a2.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=509&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/231774/original/file-20180813-2915-1owb6a2.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=509&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px"></a>
<figcaption>
<span class="caption"><em>Aedes aegypti</em> mosquito larvae swim in a container at the Florida Mosquito Control District Office in Marathon, Fla. A study released in May 2017 suggests Zika began spreading in Florida mosquitoes about three months before infections showed up in the Miami area in the summer of 2016, and the virus likely was carried in by travelers from the Caribbean.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Zika-Florida/91cc1668742e45928ef2bc67aef56efe/18/0">Wilfredo Lee / AP Photo</a></span>
</figcaption>
</figure>
<p>Genetically modifying mosquitoes to prevent disease may sound like science fiction, but the technology has advanced in recent years to the point where this is no longer a scenario relegated to late-night movies. In fact, it’s not even a new idea; scientists were talking about modifying insect populations to control diseases as <a href="http://doi.org/10.3390/ijerph14091006">early as the 1940s</a>. Today, genetically modified (GM) mosquitoes, developed during the past <a href="http://www.pnas.org/content/95/7/3743.long">several</a> <a href="https://www.nature.com/articles/417452a">decades</a> of <a href="http://www.pnas.org/content/104/13/5580.long">research</a> in <a href="http://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1001003">university</a> <a href="http://www.pnas.org/content/112/49/E6736.long">laboratories</a>, are being used to combat mosquito-borne pathogens – including viruses such as dengue and Zika – in many locations around the globe, including the United States. Progress is also being made to use GM mosquitoes to combat malaria, the most devastating mosquito-borne disease, although field releases for malaria control have not yet taken place. </p>
<p>I have been working on GM mosquitoes, both as a lab tool and to combat disease, for over 20 years. During that time, I have personally witnessed the technology go from theoretical, to seeing it used in the field. I’ve seen <a href="http://doi.org/10.3390/ijerph14091006">older techniques</a> that were inefficient, random and slow pave the way for new methods like <a href="http://doi.org/10.1016/j.celrep.2015.03.009">CRISPR</a>, which enables efficient, rapid and precise editing of mosquito genomes, and <a href="http://www.nature.com/articles/s41467-018-05425-9">ReMOT Control</a> which eliminates the requirement for injecting materials into mosquito embryos. These new technologies make GM mosquitoes for disease control not a question of “if,” but rather a question of “where” and “when.” </p>
<p>Don’t worry, these genetic changes only affect the mosquitoes – they are not transmitted to people when the mosquito bites them. </p>
<h2>Ways to use genetically modified mosquitoes</h2>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/231773/original/file-20180813-2924-1n9iixt.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/231773/original/file-20180813-2924-1n9iixt.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=421&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/231773/original/file-20180813-2924-1n9iixt.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=421&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/231773/original/file-20180813-2924-1n9iixt.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=421&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/231773/original/file-20180813-2924-1n9iixt.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=530&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/231773/original/file-20180813-2924-1n9iixt.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=530&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/231773/original/file-20180813-2924-1n9iixt.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=530&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
<figcaption>
<span class="caption">A worker sprays anti-mosquito fog in an attempt to control dengue fever at a neighborhood in Jakarta, Indonesia. Highly populated areas in the country are often hit with severe outbreaks of the mosquito-borne disease especially during the annual rainy season due to poor health services and unsanitary living conditions.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Indonesia-Daily-Life/85bc77e9a29747c588688c5391bd7159/3/0">Achmad Ibrahim / AP Photo</a></span>
</figcaption>
</figure>
<p>There are two alternative methods currently used to control mosquito-borne diseases using GM mosquitoes. The first is “population replacement” in which a mosquito population biologically able to transmit pathogens is “replaced” by one that is unable to transmit pathogens. This approach generally relies on a concept known as “gene drive” to spread the anti-pathogen genes. In gene drive, a genetic trait – a gene or group of genes – relies on a quirk on inheritance to spread to more than half of a mosquito’s offspring, boosting the frequency of the trait in the population.</p>
<p>The second approach is called “population suppression.” This strategy reduces mosquito populations so that there are fewer mosquitoes to pass on the <a href="http://doi.org/10.1371/journal.pntd.0000508">pathogen</a>. </p>
<p>While the concept of <a href="http://doi.org/10.1073/pnas.1521077112">gene drive in mosquitoes</a> is <a href="http://www.mdpi.com/1660-4601/14/9/1006">many decades old</a>, the gene-editing technique CRISPR has finally made it possible to easily engineer it in the laboratory. However, CRISPR-based gene drives have not yet been deployed in nature, mostly because they are still a new technology that lacks a firm international regulatory framework, but also due to problems related to the <a href="http://journals.plos.org/plosgenetics/article?id=10.1371/journal.pgen.1006796">evolution of resistance</a> in mosquito populations that will stop the gene from spreading.</p>
<p>It may not be immediately obvious, but the gene in “gene drive” need not be a gene at all – it can be a microbe. All organisms exist not just with their own genomes, but also with the genomes of all their associated microbes – the “hologenome.” Spread of a microbial genome through a population by inheritance can also be thought of as gene drive. By this definition, the first gene drive that has been deployed in mosquito populations for disease control is a bacterial symbiont known as <em>Wolbachia</em>. <em>Wolbachia</em> is a bacterium that infects up to 70 percent of all known insect species, where it hijacks the insect reproduction to spread itself through the population. </p>
<p>Thus, the <em>Wolbachia</em> itself (with its genome of approximately 1,500 genes) acts as the genetic trait that is driven into the population. When <em>Wolbachia</em> is transferred into a previously uninfected mosquito, it often makes the mosquito more resistant to infection with pathogen that can cause disease in humans, such as multiple viruses (including <a href="https://www.nature.com/articles/nature10355">dengue</a> and <a href="https://www.sciencedirect.com/science/article/pii/S1931312816301573?via%3Dihub">Zika</a> viruses) and <a href="http://doi.org/10.1371/journal.ppat.1002043">malaria parasites</a>.</p>
<h2>A bacterium that fights disease</h2>
<figure class="align-center ">
<img alt="" src="https://images.theconversation.com/files/231775/original/file-20180813-2894-1rqbhre.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/231775/original/file-20180813-2894-1rqbhre.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=405&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/231775/original/file-20180813-2894-1rqbhre.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=405&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/231775/original/file-20180813-2894-1rqbhre.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=405&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/231775/original/file-20180813-2894-1rqbhre.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=509&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/231775/original/file-20180813-2894-1rqbhre.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=509&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/231775/original/file-20180813-2894-1rqbhre.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=509&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Resident Annick Sternberg, left, releases <em>Wolbachia</em>-infected male mosquitoes, as Bill Petrie, director of Miami-Dade County Mosquito Control, center, looks on in South Miami, Fla., Feb. 8, 2018. Thousands of bacteria-infected mosquitoes are flying near Miami to test a new way to suppress insect populations that carry Zika and other viruses. At right is Patrick Kelly, field operations manager for Mosquito Mate.</span>
<span class="attribution"><a class="source" href="http://www.apimages.com/metadata/Index/Modified-Mosquitoes/d689afb66095432f857ac61123442f36/4/0">Lynne Sladky/AP Photo</a></span>
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<p>In the last eight years, researchers have taken <em>Wolbachia</em> present in fruit flies and <a href="http://doi.org/10.1038/nature10356">transferred that bacteria into mosquitoes that transmit dengue virus.</a> Those modified insects were then released <a href="https://www.worldmosquitoprogram.org">in a dozen countries to control the disease</a>. Although marketed as a “non-GM strategy,” artificially infecting mosquitoes with <em>Wolbachia</em> clearly falls under the GM umbrella, as over 1,500 genes (the entire bacterial genome) have been transferred from the original fruit fly host into the mosquitoes. </p>
<p><a href="https://gatesopenresearch.org/articles/2-36/v1">Preliminary</a> dengue control results from these releases in Australia have been promising. However, control of the disease in other release areas with higher disease risk, such as South America and Asia, still needs to be determined, particularly as some <a href="http://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0002965">studies</a> <a href="https://aem.asm.org/content/78/5/1491">have</a> <a href="http://journals.plos.org/plospathogens/article?id=10.1371/journal.ppat.1004182">demonstrated</a> <a href="http://rspb.royalsocietypublishing.org/content/281/1779/20132837.long">that</a> <a href="http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0059619"><em>Wolbachia</em></a> can sometimes increase pathogen infection in mosquitoes rather than suppress it. </p>
<h2>GM mosquitoes that eliminate mosquitoes</h2>
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<img alt="" src="https://images.theconversation.com/files/232490/original/file-20180817-165934-1w65rx4.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;fit=clip" srcset="https://images.theconversation.com/files/232490/original/file-20180817-165934-1w65rx4.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=600&amp;h=398&amp;fit=crop&amp;dpr=1 600w, https://images.theconversation.com/files/232490/original/file-20180817-165934-1w65rx4.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=600&amp;h=398&amp;fit=crop&amp;dpr=2 1200w, https://images.theconversation.com/files/232490/original/file-20180817-165934-1w65rx4.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=600&amp;h=398&amp;fit=crop&amp;dpr=3 1800w, https://images.theconversation.com/files/232490/original/file-20180817-165934-1w65rx4.jpg?ixlib=rb-1.1.0&amp;q=45&amp;auto=format&amp;w=754&amp;h=501&amp;fit=crop&amp;dpr=1 754w, https://images.theconversation.com/files/232490/original/file-20180817-165934-1w65rx4.jpg?ixlib=rb-1.1.0&amp;q=30&amp;auto=format&amp;w=754&amp;h=501&amp;fit=crop&amp;dpr=2 1508w, https://images.theconversation.com/files/232490/original/file-20180817-165934-1w65rx4.jpg?ixlib=rb-1.1.0&amp;q=15&amp;auto=format&amp;w=754&amp;h=501&amp;fit=crop&amp;dpr=3 2262w" sizes="(min-width: 1466px) 754px, (max-width: 599px) 100vw, (min-width: 600px) 600px, 237px">
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<span class="caption">Estimated range of the dengue and Zika virus carrying mosquito species in the United States, <em>Aedes aegypti</em>, blue, and <em>Aedes albopictus</em>, red. States and territories where both species have been collected are purple. All U.S. states and territories except Alaska are at risk for West Nile virus.</span>
<span class="attribution"><span class="source">Jason Rasgon</span>, <a class="license" href="http://creativecommons.org/licenses/by-nd/4.0/">CC BY-ND</a></span>
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<p>The best current example of population suppression is the release of genetically modified sterile mosquitoes. This is a modern spin on the decades-old Sterile Insect Technique (SIT), where sterile male insects are released into natural populations to mate with the wild females, reducing the mosquito population. But, rather than crudely sterilizing mosquitoes with radiation or chemicals, clever genetic engineering is now used to sterilize them instead. The <a href="http://doi.org/10.1371/journal.pntd.0003864">company Oxitec has engineered mosquitoes with a gene that is lethal to females but not to males</a>, which do not bite or transmit disease. Thousands of these transgenic males are released into nature, where they mate with the wild females in the population. The genetic modification is inherited by the offspring of these matings; female offspring die, while male offspring, which carry the gene, survive and continue passing the trait to further generations. With fewer and fewer females the mosquito population is drastically suppressed. Oxitec has conducted releases in the <a href="https://www.caymancompass.com/2017/10/24/genetically-modified-mosquitoes-in-cayman-swat-wild-population/">Grand Caymans</a>, <a href="http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0042771">Malaysia</a>, <a href="http://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0003864">Brazil</a>, and <a href="https://www.cnn.com/2017/04/20/health/florida-mosquito-wolbachia-trial-zika/index.html">Florida</a>.</p>
<p>There has been some opposition to these sterile mosquito releases, particularly in Florida. For example, in 2016, <a href="https://e360.yale.edu/features/genetically_modified_mosquito_sparks_a_controversy_in_florida">an Oxitec trial in the Florida Keys was met with some local resistance</a>. However, unlike gene drive strategies, release of sterile mosquitoes (genetically modified or not) has about the smallest environmental footprint and highest safety of any disease control strategy; certainly safer than broad-spectrum insecticide sprays. It is highly targeted, and thus if it works, will only result in elimination of the target mosquito species, which in this case (<em>Aedes aegypti</em>) is a highly invasive and non-native mosquito in Florida. </p>
<p>In addition to gene drive, <em>Wolbachia</em> bacteria have also been used for population suppression. Males infected with the bacteria are released into a mosquito population that is either not infected, or infected with a different <em>Wolbachia</em> strain, which leads to “incompatible” or sterile matings. This strategy again has a long history, and was <a href="http://doi.org/10.3390/ijerph14091006">first used to suppress mosquito populations</a> in the 1960s before people even knew that <em>Wolbachia</em> was causing certain populations of mosquitoes to be sterile when mated with one another. In current times, <a href="http://doi.org/10.1038/srep33846"><em>Wolbachia</em>-sterilized males have been released in multiple countries</a> including Australia and the U.S., in California and Florida, to control dengue virus.</p>
<p>In an increasingly interconnected world, and with the added problems of <a href="https://www.sciencedirect.com/science/article/pii/S1471492217302805?via%3Dihub">global climate change</a>, pathogens are not likely to stay confined to the developing world, but will be an increasing issue for the U.S. as well. With the evolution of insecticide resistance in mosquitoes a certainty, GM technology has the potential to reduce the burden of mosquito-borne diseases across the globe, without the environmental and health risks associated with harmful pesticide use. </p>
<p>Don’t be afraid if it sounds like science fiction; it may just save your life.</p><img src="https://counter.theconversation.com/content/100719/count.gif" alt="The Conversation" width="1" height="1" />
<p class="fine-print"><em><span>Jason Rasgon receives funding from the National Institutes of Health, and the National Science Foundation</span></em></p>For several billion people mosquitoes are more than a nuisance -- they transmit deadly diseases. Now genetic modification may prove the most effective defense against the mosquito, preventing disease.Jason Rasgon, Professor of Entomology and Disease Epidemiology, Pennsylvania State UniversityLicensed as Creative Commons – attribution, no derivatives.